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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 63122
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-31
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 including the states of: AK, CA, IL, FL, HI, MI, MO, NC, NJ, NY, OH, PA, TX and the countries of Germany, Brazil, Canada, Japan, Taiwan, Thailand, India and Korea.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Multipolar® Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar® Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a popping sound as conformation that the femoral head has completed seated, as noted in surgical technique 97-5003-003-00 Item 00-5001-040- 22; Lot 61261192, 61261194, 61296091, Class II Zimmer Inc. is initiating a removal of the Multipolar® Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled. 195 Z-0410-2013