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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Trabecular Metal Shoulder, humeral stem

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  Class 2 Device Recall Zimmer Trabecular Metal Shoulder, humeral stem see related information
Date Initiated by Firm September 17, 2009
Date Posted November 12, 2009
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-0178-2010
Recall Event ID 53536
510(K)Number K041549  
Product Classification Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code HSD
Product Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13.

Shoulder replacement surgery.
Code Information Lot 60947164.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 Some of the devices may possess a taper which will not mate with the humeral head, as intended.
FDA Determined
Cause 2		 Other
Action Zimmer distributors were notified by email on 9/19/09 to locate and return the products. Letter dated 9/29/09 were sent to the Zimmer salesforce and distributors with a letter to be given to each affected hospital account to inform them of the problem. Zimmer accounts were again asked to locate and return the devices. Hospital accounts were requested to consider the available facts when monitoring potentially affected patients.
Quantity in Commerce 12
Distribution Nationwide.
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 = HSD and Original Applicant = ZIMMER, INC.
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