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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
Recall Number Z-1996-2013
Classification Class II
Code Info Lot Number 12LM03798
Product Distributed Qty 9 units
Reason For Recall The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).

Event Detail

Event Id 65738
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew Inc
City Memphis
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-08
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern International only: Germany, France, United Arab Emirates, and United Kingdom.