Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.
FDA device recall Z-0561-04 · posted 2004-02-27 · Terminated
Recall details
- Recalling firm
- Pioneer Surgical Technology
- Reason for recall
- Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
- Action taken
- Zimmer was notified of this recall via letter dated 1/20/04 requesting Zimmer to remove all of this lot from inventory and from point of use locations.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 318
- Distribution
- By Zimmer: Nationwide, Australia, Canada, Germany and United Kingdom.
- Date initiated
- 2004-01-20
- Date posted
- 2004-02-27
- Date terminated
- 2004-05-20
- Location
- Marquette, MI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAYFUSE (K990804) | Pioneer Surgical Technology | 1999-04-29 |