StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer
FDA device recall Z-0948-03 · posted 2003-06-21 · Terminated
Recall details
- Recalling firm
- Pioneer Surgical Technology
- Reason for recall
- Label may bear an incorrect part number [2227-02-02] and size [03.8MM].
- Action taken
- A recall letter dated 5/28/03 was sent to the sole distributor, asking them to recall from their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 159
- Distribution
- Indiana
- Date initiated
- 2003-05-28
- Date posted
- 2003-06-21
- Date terminated
- 2003-09-12
- Location
- Marquette, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAYFUSE (K990804) | Pioneer Surgical Technology | 1999-04-29 |