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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Recall Number Z-1376-2013
Classification Class II
Code Info Part No. 00-5887-052-00; lots 62181290 and 62183430
Product Distributed Qty 69 units
Reason For Recall Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.

Event Detail

Event Id 65042
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-27
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide Distribution.