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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Event Detail

Event ID 66333
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew Inc
City Memphis
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-27
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 including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic Batch No. 12GT20940 Class II The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. 8 pieces Z-0449-2014
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic Batch No. 12GT20904 Class II The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. 32 pieces Z-0447-2014
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic Batch No. 12GT20822 Class II The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. 80 pieces Z-0446-2014
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic Batch No. 12GT20824 Class II The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. 45 pieces Z-0445-2014
GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic Batch No. 12GT20908 Class II The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. 16 pieces Z-0444-2014
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic Batch No. 12GT20775 Class II The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. 46 pieces Z-0448-2014
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