| Class 2 Device Recall Zimmer ZMR | |
Date Initiated by Firm | August 02, 2006 |
Date Posted | August 31, 2006 |
Recall Status1 |
Terminated 3 on May 04, 2007 |
Recall Number | Z-1476-06 |
Recall Event ID |
35943 |
510(K)Number | K994286 |
Product Classification |
hip prosthesis - Product Code LPH
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Product | Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, spout body, size D, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9990-20-46 (Cat. no. 00999002046). |
Code Information |
Lot 60465192. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
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For Additional Information Contact | Connie Morgan 800-846-4637 |
Manufacturer Reason for Recall | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand. |
Quantity in Commerce | 181 of all devices |
Distribution | Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland. |
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 = LPH
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