| | Class 2 Device Recall Zimmer ZMR |  |
| Date Initiated by Firm | August 02, 2006 |
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| Date Posted | August 31, 2006 |
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| Recall Status1 |
Terminated 3 on May 04, 2007 |
| Recall Number | Z-1478-06 |
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| Recall Event ID |
35943 |
| 510(K)Number | K994286 |
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| 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, standard, 40 mm neck offset, cone body, size C, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-35 (Cat. no. 00999601935). |
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| Code Information |
Lot 60454259. |
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 |
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Manufacturer Reason
for Recall | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | 181 of all devices |
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| Distribution | Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland. |
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| 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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