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U.S. Department of Health and Human Services

Class 2 Device Recall Moore Hip Prosthesis Long Fenestrated Stem

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 Class 2 Device Recall Moore Hip Prosthesis Long Fenestrated Stem see related information
Date Posted August 17, 2013
Recall Status1 Terminated on April 30, 2015
Recall Number Z-1981-2013
Recall Event ID 65833
Product Classification Prosthesis, hip, femoral component, cemented, metal - Product Code JDG
Product Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length.

Used to seat the prosthesis with or without bone cement.
Code Information 25621400
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Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
800-613-6131
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall
Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration, which
FDA Determined
Cause 2
Packaging process control
Action Zimmer is removing the devices from the field including distributor and hospital inventories. A notification was issued to known users of the product on 07/16/2013.
Quantity in Commerce 1,710 units are in distribution
Distribution Worldwide Distribution-USA (nationwide) including the states of CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI, and the countries of Singapore, Canada, Mexico, Arab Emirates, Saudi Arabia, and Hong Kong.
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.
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