Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -ex
FDA device recall Z-1472-06 · 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 |
|---|---|---|
| TRABECULAR METAL PRIMARY HIP PROSTHESIS (K051491) | Zimmer, Inc. | 2005-06-30 |