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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Alumina Ceramic Femoral Head

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  Class 2 Device Recall Zimmer Alumina Ceramic Femoral Head see related information
Date Initiated by Firm May 29, 2009
Date Posting Updated July 27, 2009
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-1616-2009
Recall Event ID 52169
510(K)Number K030724  
PMA Number P040048 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; Catalog Number: 6428-32-02.

Orthopedic implant used in total hip arthroplasty.
Code Information Lot Number: 61007046.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall
The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.
FDA Determined
Cause 2
Packaging process control
Action Zimmer, Inc. issued "Urgent: Device Recall" notices dated May 29, 2009 informing Consignees of the affected devices. Users were instructed to locate and return affected product and complete and return an Inventory Return Certification form via fax to the firm at 1-547-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.
Quantity in Commerce 147 of both products
Distribution Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZO and Original Applicant = ZIMMER, INC.
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