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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Kinectivo Technology Modular Neck

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 Class 2 Recall
Zimmer Kinectivo Technology Modular Neck
see related information
Date Posted July 27, 2009
Recall Status1 Terminated on December 22, 2009
Recall Number Z-1617-2009
Recall Event ID 52169
Premarket Notification
510(K) Numbers
K030724  K063251 
Premarket Approval
PMA Number
P040048
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
Product Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01. Orthopedic implant used in total hip arthroplasty.
Code Information Lot Number: 60917793.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
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
PRODUCTION CONTROLS: 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 = LPH and Original Applicant = ZIMMER, INC.
PMA Database PMAs with Product Code = LPH and Applicant = ZIMMER, INC.
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