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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65413
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-07
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution-USA (nationwide) and the country of Japan.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF AE56/STR GRN 14MM, Rx, Sterile; 90597004117 Articular Surface CR ART SURF AE56/STR GRN 17MM, Rx, Sterile; 90597004120 Articular Surface CR ART SURF AE56/STR GRN 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2031-2013
00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; 00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10, Rx, Sterile; 00597004112 Articular Surface CR ART SURF 56/STRIPE GREEN 12, Rx, Sterile; 00597004114 Articular Surface CR ART SURF 56/STRIPE GREEN 14, Rx, Sterile; 00597004117 Articular Surface CR ART SURF 56/STRIPE GREEN 17, Rx, Sterile; 00597004120 Articular Surface CR ART SURF 56/STRIPE GREEN 20, Rx, Sterile; 00597004123 Articular Surface CR ART SURF 56/STRIPE GREEN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2030-2013
90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; 90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2029-2013
00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile; 00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14, Rx, Sterile; 00595204117 Articular Surface XLPE CR ART SURF 5-6/STRGRN 17, Rx, Sterile; 00595204120 Articular Surface XLPE CR ART SURF 5-6/STRGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2028-2013
00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2027-2013
00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2000-2013
00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM CO-NID BML, Rx, Sterile; 00597001232 Femur CR PRC SURF HDN FEM CO-NID BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-1999-2013
00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. Used in total knee arthroplasty and indicated for patients with severe pain. REF 00597001101, all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-1998-2013
00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597203112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597203114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597203117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597203120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597203123 Articular Surface CR ART SURF 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2026-2013
90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile; 90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM, Rx, Sterile; 90597003114 Articular Surface CR ART SURF 34/STR YEL 14MM, Rx, Sterile; 90597003117 Articular Surface CR ART SURF 34/STR YEL 17MM, Rx, Sterile; 90597003120 Articular Surface CR ART SURF 34/STR YEL 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2025-2013
00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597003117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597003120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597003123 Articular Surface CR ART SURF 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2024-2013
90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; 90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2023-2013
00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, Rx, Sterile; 00595203114 Articular Surface XLPE CR ART SURF 3,4/SYEL 14, Rx, Sterile; 00595203117 Articular Surface XLPE CR ART SURF 3,4/SYEL 17, Rx, Sterile; 00595203120 Articular Surface XLPE CR ART SURF 3,4/SYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2022-2013
00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012 Articular Surface AC ART SURF 12/PUR 12, Rx, Sterile; 00597602014 Articular Surface AC ART SURF 12/PUR 14, Rx, Sterile; 00597602017 Articular Surface AC ART SURF 12/PUR 17, Rx, Sterile; 00597602020 Articular Surface AC ART SURF 12/PUR 20, Rx, Sterile; 00597602023 Articular Surface AC ART SURF 12/PUR 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2021-2013
00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597202017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597202020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597202023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2020-2013
90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM, Rx, Sterile; 90597002017 Articular Surface CR ART SURF 12/PURPLE 17MM, Rx, Sterile; 90597002020 Articular Surface CR ART SURF 12/PURPLE 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2019-2013
00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597002017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597002020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597002023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2018-2013
90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2017-2013
00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597104120 Provisional CR ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597104123 Provisional CR ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2044-2013
00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Sterile; 00597103114 Provisional CR ART SURF PROV 34/STR YEL 14, Rx, Sterile; 00597103117 Provisional CR ART SURF PROV 34/STR YEL 17, Rx, Sterile; 00597103120 Provisional CR ART SURF PROV 34/STR YEL 20, Rx, Sterile; 00597103123 Provisional CR ART SURF PROV 34/STR YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2043-2013
00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF 1,2/PUR 17, Rx, Sterile; 00595202020 Articular Surface XLPE CR ART SURF 1,2/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2016-2013
00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2015-2013
00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2014-2013
65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile; 65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile; 65597201434 Femur CR POR FEM SURF HDN HATCP DMR, Rx, Sterile; 65597201533 Femur CR POR FEM SURF HDN HATCP EML, Rx, Sterile; 65597201534 Femur CR POR FEM SURF HDN HATCP EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2013-2013
00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533 Femur CR POR SURF HDN FEM CO-NID EML, Rx, Sterile; 00597201534 Femur CR POR SURF HDN FEM CO-NID EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2012-2013
00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Sterile; 00597102020 Provisional CR ART SURF PROV 12/PURPLE 20, Rx, Sterile; 00597102023 Provisional CR ART SURF PROV 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2042-2013
00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597504112 Provisional AC ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597504114 Provisional AC ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597504117 Provisional AC ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597504120 Provisional AC ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597504123 Provisional AC ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2041-2013
00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 00597503112 Provisional AC ARTSURF PROV 34/STRIPE YEL12, Rx, Sterile; 00597503114 Provisional AC ARTSURF PROV 34/STRIPE YEL14, Rx, Sterile; 00597503117 Provisional AC ARTSURF PROV 34/STRIPE YEL17, Rx, Sterile; 00597503120 Provisional AC ARTSURF PROV 34/STRIPE YEL 20, Rx, Sterile; 00597503123 Provisional AC ARTSURF PROV 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2040-2013
00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile; 00597502020 Provisional AC ART SURF PROV 12/PUR 20, Rx, Sterile; 00597502023 Provisional AC ART SURF PROV 12/PUR 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2039-2013
00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile; 00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Sterile; 00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2038-2013
00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx, Sterile; 00597201504 Femur CR POR FM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2011-2013
00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx, Sterile; 00597001533 Femur CR PRC SURF HDN FEM CO-NID EML Rx, Sterile; 00597001534 Femur CR PRC SURF HDN FEM CO-NID EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2010-2013
00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Femur CR PRC FEM COMP SIZE DML Rx, Sterile; 00597001404 Femur CR PRC FEM COMP SIZE DMR Rx, Sterile; 00597001503 Femur CR PRC FEM COMP SIZE EML Rx, Sterile; 00597001504 Femur CR PRC FEM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 Z-2009-2013
65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2008-2013
00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2007-2013
00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2037-2013
00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2036-2013
00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2035-2013
00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102 Provisional CR PROV FRM COMP SIZE AMR, Rx, Sterile; 00597101201 Provisional CR PROV FRM COMP SIZE BML, Rx, Sterile; 00597101202 Provisional CR PROV FRM COMP SIZE BMR, Rx, Sterile; 00597101303 Provisional CR PROV FRM COMP SIZE CML, Rx, Sterile; 00597101304 Provisional CR PROV FRM COMP SIZE CMR, Rx, Sterile; 00597101403 Provisional CR PROV FRM COMP SIZE DML, Rx, Sterile; 00597101404 Provisional CR PROV FRM COMP SIZE DMR, Rx, Sterile; 00597101503 Provisional CR PROV FRM COMP SIZE EML, Rx, Sterile; 00597101504 Provisional CR PROV FRM COMP SIZE EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2034-2013
00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; 00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12, Rx, Sterile; 00597604114 Articular Surface AC ART SURF 56/STRIPED GRN 14, Rx, Sterile; 00597604117 Articular Surface AC ART SURF 56/STRIPED GRN 17, Rx, Sterile; 00597604120 Articular Surface AC ART SURF 56/STRIPED GRN 20, Rx, Sterile; 00597604123 Articular Surface AC ART SURF 56/STRIPED GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2033-2013
00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx, Sterile; 00597204112 Articular Surface CR ART SURF 56/STRIPE GRN 12, Rx, Sterile; 00597204114 Articular Surface CR ART SURF 56/STRIPE GRN 14, Rx, Sterile; 00597204117 Articular Surface CR ART SURF 56/STRIPE GRN 17, Rx, Sterile; 00597204120 Articular Surface CR ART SURF 56/STRIPE GRN 20, Rx, Sterile; 00597204123 Articular Surface CR ART SURF 56/STRIPE GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2032-2013
00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 00595001202 Femur CR-FLEX PCT FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 Z-2006-2013
00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2005-2013
00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femur CRA PRECOAT FEM COMP SIZE B/R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2004-2013
65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2003-2013
00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile; 00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 all devices Z-2002-2013
65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain. all codes Class II Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan. 192,355 Z-2001-2013
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