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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Recall Number Z-2092-2012
Classification Class II
Code Info Part 00-5901-026-40 Lot 62011774, 61870067, and 61813699 Initially the 00-5901-026-40 replacement jaws will remain available for order until all of the alternative instruments are in place, however they will also be required to be returned. The final lot numbers and manufacture dates will be provided in a subsequent status update.
Product Distributed Qty 65 units
Reason For Recall Postmarket reports indicate that the spring clip may fracture or fall off of the instrument during use, posing the risk that a device fragment may be left in the surgical site. The risk of disassembly or fracture appears to be happening during use of this instrument where the instrument is typically impacted with a mallet to aid in insertion. The applied forces are contributing to the instrument fractures. The fracture of the spring clip is an unintended use oft he product. Zimmer initiated a recall of this instrument in March 2011, at which time an updated design to the spring clip for the jaw assembly was implemented due to fractures of the spring clip. Zimmer has received 62 complaints (as of April 25, 2012) for the spring clip fracturing on the updated design.

Event Detail

Event Id 61764
Product Type Devices
Status Ongoing
Recalling Firm Zimmer Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-30
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 (nationwide) and the countries of Singapore, China, Hong Kong,Canada, Australia, Japan, Europe, Germany, India, and Finland.