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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Detail

Product Description Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert the drill into the tibial bone.
Recall Number Z-2493-2012
Classification Class II
Code Info Part 42-5399-018-00, Lots 62034571, 62089766
Product Distributed Qty 60
Reason For Recall Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone. The investigation into the reports that have been received found that the perforations are occurring while using the Cemented Tibial Drill. The perforations have occurred in the anterior medial tibial cortex, particularly when preparing for a size E tibial plate. As a result of this investigation, Zimmer is detailing below some important aspects within the surgical technique that mitigate the potential of perforating the tibial cortex. In addition, Zimmer is replacing the current Cemented Tibial Drill with a modified version that has relocated the depth indicators for determining how deep to drill for the different sizes of tibial plates. Concurrent with delivery of this notification, your sales representative is replacing your Cemented Tibial Drill.

Event Detail

Event Id 63125
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - US Nationwide including the states of: AZ, CA, CO,FL, MN, IL, NJ, NY, OH, OR and the countries of Austrailia, Utd. Arab Emir., France, Germany, India, and Italy.