Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by
FDA device recall Z-0872-06 · posted 2006-05-18 · Terminated
Recall details
- Recalling firm
- Pioneer Surgical Technology
- Reason for recall
- There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended.
- Action taken
- Pioneer notified Zimmer via letter dated 3/3/06 and Zimmer notified their hospital customers and distribution sites via letters dated 3/10/06 to check their inventory and return the product immediately to Zimmer.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 74
- Distribution
- Nationwide.
- Date initiated
- 2006-03-03
- Date posted
- 2006-05-18
- Date terminated
- 2007-12-04
- Location
- Marquette, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CANNULATED SCREW SYSTEM (K003496) | Pioneer Surgical Technology | 2001-02-08 |