Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 12, standard body
FDA device recall Z-0473-03 · posted 2003-01-28 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
- Action taken
- Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPH
- Distribution
- United States, Australia and Canada.
- Date initiated
- 2003-01-07
- Date posted
- 2003-01-28
- Date terminated
- 2004-02-09
- 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 |
|---|---|---|
| ZIMMER ANATOMIC HIP SYSTEM (K922071) | Zimmer, Inc. | 1994-02-22 |