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U.S. Department of Health and Human Services

Class 2 Device Recall Multipolar

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 Class 2 Recall
Multipolar
see related information
Date Posted November 20, 2012
Recall Status1 Terminated on September 23, 2013
Recall Number Z-0410-2013
Recall Event ID 63122
Premarket Notification
510(K) Number
K833991 
Product Classification Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented - Product Code KWY
Product 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
Code Information Item 00-5001-040- 22; Lot 61261192, 61261194, 61296091,
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
For Additional Information Contact Dona Reust
574-372-4807
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Process Design
Action Zimmer sent an Urgent Medical Device Recall letter to all affected consignees during the week of September 3, 2012. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, quarantine the recalled product and return remaining inventory. Customers were advised to complete Inventory Return Certification form attached.
Quantity in Commerce 195
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWY and Original Applicant = ZIMMER, INC.
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