Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body
FDA device recall Z-1478-06 · posted 2006-08-31 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 181 of all devices
- Distribution
- Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.
- Date initiated
- 2006-08-02
- Date posted
- 2006-08-31
- Date terminated
- 2007-05-04
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZMR HIP SYSTEM-POROUS REVISION (K994286) | Zimmer, Inc. | 2000-03-10 |