Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem len
FDA device recall Z-1468-06 · 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
- LWJ
- 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DELTA HIP PROSTHESIS (K961378) | Zimmer, Inc. | 1996-10-08 |