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U.S. Department of Health and Human Services

Medical Device Recalls

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Product: kne
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NexGen® Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Numb... 2 12/18/2018 Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108 2 11/21/2018 Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 2 11/21/2018 Zimmer Biomet, Inc.
Neodent® GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prostheti... 2 11/14/2018 Straumann Manufacturing, Inc.
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Prod... 2 11/02/2018 Howmedica Osteonics Corp.
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System /... 2 10/11/2018 Brainlab AG
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111 2 10/02/2018 ConforMIS, Inc.
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 7402311... 2 10/01/2018 Smith & Nephew, Inc.
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 7402111... 2 10/01/2018 Smith & Nephew, Inc.
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, ... 2 10/01/2018 Smith & Nephew, Inc.
Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for ... 2 09/26/2018 Zimmer Biomet, Inc.
Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 I... 2 09/25/2018 Zimmer Biomet, Inc.
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 ... 2 09/25/2018 Zimmer Biomet, Inc.
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicat... 2 09/20/2018 Exactech, Inc.
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage:... 2 09/15/2018 Mako Surgical Corporation
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Founda... 2 08/31/2018 Encore Medical, Lp
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 2 08/29/2018 DePuy Orthopaedics, Inc.
Stryker Mako Vizadisc Knee Procedure Tracking Kit 2 08/24/2018 Mako Surgical Corporation
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthe... 2 08/22/2018 Smith & Nephew, Inc.
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: ... 2 08/18/2018 Zimmer Biomet, Inc.
Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Applicati... 2 08/14/2018 Mako Surgical Corporation
Think Surgical Cutter, Flat, ®6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Pa... 2 08/06/2018 Think Surgical, Inc.
Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shou... 2 07/13/2018 Valeris Medical, LLC
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-... 2 07/11/2018 Anika Therapeutics, Inc.
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 ... 2 06/04/2018 Zimmer Biomet, Inc.
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replac... 2 06/01/2018 Zimmer Biomet, Inc.
Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 14... 2 06/01/2018 Zimmer Biomet, Inc.
smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS ... 2 05/21/2018 Smith & Nephew, Inc.
Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements... 2 05/04/2018 Mako Surgical Corporation
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee 2 04/30/2018 DePuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee 2 04/30/2018 DePuy Orthopaedics, Inc.
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 ... 2 04/25/2018 Zimmer Biomet, Inc.
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended... 2 04/24/2018 Howmedica Osteonics Corp.
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are s... 2 04/20/2018 Howmedica Osteonics Corp.
Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery 2 03/28/2018 Zimmer Biomet, Inc.
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm ... 2 03/28/2018 Zimmer Biomet, Inc.
PERSONA® THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe ... 2 03/27/2018 Zimmer Biomet, Inc.
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERI... 2 03/19/2018 Smith & Nephew, Inc.
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is int... 2 03/19/2018 OMNIlife science Inc.
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032... 2 03/19/2018 United Orthopedic Corporation
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total K... 2 03/19/2018 United Orthopedic Corporation
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty 2 03/14/2018 Zimmer Biomet, Inc.
LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ ... 2 03/14/2018 Zimmer Biomet, Inc.
LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS ... 2 03/14/2018 Zimmer Biomet, Inc.
LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability 2 03/14/2018 Zimmer Biomet, Inc.
NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATUR... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP F... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-F... 2 03/14/2018 Zimmer Biomet, Inc.
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT® N-K FLX GSM POR FEM SZ 2 RT N-K FL... 2 03/14/2018 Zimmer Biomet, Inc.
CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis 2 03/14/2018 Zimmer Biomet, Inc.
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS®... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX GSF PRECOAT SZ C-L® CR-FLEX GSF PRECOAT SZ C-R® CR-FLEX GSF PRECOAT SZ D-L® CR-FLEX GSF P... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX GSF PCT SZ C-R MINUS® CR-FLEX GSF PCT SZ D-L MINUS® CR-FLEX GSF PCT SZ D-R MINUS® CR-FLEX... 2 03/14/2018 Zimmer Biomet, Inc.
NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT® " These devices are indicated for patients with... 2 03/14/2018 Zimmer Biomet, Inc.
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM ... 2 03/14/2018 Zimmer Biomet, Inc.
ZUK PRC FEM SZB RMED/LLAT® ZUK PRC FEM SZC LMED/RLAT® ZUK PRC FEM SZC RMED/LLAT® NGU PRC FEM SZD ... 2 03/14/2018 Zimmer Biomet, Inc.
PRCT MIS CR MOB PLT SZ 4 L® PRCT MIS CR MOB PLT SZ 5 L® PRCT MIS CR MOB PLT SZ 6 L® PRCT MIS CR M... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM ... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for ... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM ... 2 03/14/2018 Zimmer Biomet, Inc.
CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L... 2 03/14/2018 Zimmer Biomet, Inc.
NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee ... 2 03/14/2018 Zimmer Biomet, Inc.
LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX P... 2 03/14/2018 Zimmer Biomet, Inc.
LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTI... 2 03/14/2018 Zimmer Biomet, Inc.
CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM... 2 03/14/2018 Zimmer Biomet, Inc.
CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT... 2 03/14/2018 Zimmer Biomet, Inc.
LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is ind... 2 03/14/2018 Zimmer Biomet, Inc.
LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS ... 2 03/14/2018 Zimmer Biomet, Inc.
LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patien... 2 03/14/2018 Zimmer Biomet, Inc.
LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L ... 2 03/14/2018 Zimmer Biomet, Inc.
O-arm® O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Ima... 2 03/08/2018 Medtronic Navigation, Inc.-Littleton
OTTO BOCK Kenevo knee joints Model 3C60 2 03/01/2018 Otto Bock Healthcare Product
OTTO BOCK Kenevo knee joints Model 3C60=ST 2 03/01/2018 Otto Bock Healthcare Product
AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02 2 02/28/2018 Avid Medical, Inc.
The 2nd Assist Knee Positioner 2 02/28/2018 Zimmer Biomet, Inc.
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED ... 2 02/26/2018 Zimmer Biomet, Inc.
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201)... 2 02/26/2018 Zimmer Biomet, Inc.
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joi... 2 02/21/2018 ZIMMER ORTHOPEDIC MFG LTD
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Pr... 2 02/21/2018 Zimmer Biomet, Inc.
Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product U... 2 02/21/2018 Zimmer Biomet, Inc.
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The fir... 2 02/16/2018 Oculus Optikgeraete GMBH
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For... 2 02/15/2018 Zimmer Biomet, Inc.
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For ... 2 02/15/2018 Zimmer Biomet, Inc.
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used ... 2 02/14/2018 Zimmer Biomet, Inc.
Synvisc-One ® (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous h... 2 02/14/2018 Sanofi Genzyme
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- an... 2 02/13/2018 ConforMIS, Inc.
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST046... 2 02/12/2018 Aesculap Implant Systems LLC
Persona Partial Knee System, Size 8, Finishing Guide 2 01/14/2018 Zimmer Biomet, Inc.
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Contai... 2 01/12/2018 DeRoyal Industries Inc
EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in ortho... 2 01/10/2018 Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthope... 2 01/10/2018 Encore Medical, Lp
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthope... 2 01/10/2018 Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthop... 2 01/10/2018 Encore Medical, Lp

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
 
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