Date Initiated by Firm | July 20, 2006 |
Date Posted | August 26, 2006 |
Recall Status1 |
Terminated 3 on December 19, 2007 |
Recall Number | Z-1417-06 |
Recall Event ID |
35942 |
510(K)Number | K052906 |
Product Classification |
Shoulder system, reverse - Product Code KWT
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Product | Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01. |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact | 800-846-4637 |
Manufacturer Reason for Recall | Components may not lock together as intended. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified via recall letter dated 7/20/06 to cease use of the products and to return the product to Zimmer. |
Quantity in Commerce | 197 for all three recalls Z-1416-1418-06 |
Distribution | Worldwide distribution --- USA and countries of Australia and China |
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 = KWT
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