| Class 2 Device Recall Zimmer Trabecular Metal Shoulder, humeral stem |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HSD
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