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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
Recall Number Z-0130-2014
Classification Class II
Code Info Batch No. 13GM11272
Product Distributed Qty 4 units
Reason For Recall Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Event Detail

Event Id 66545
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew Inc
City Memphis
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.