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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 Posted July 27, 2009
Recall Status1 Terminated 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/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
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 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 = LZO and Original Applicant = ZIMMER, INC.
PMA Database