Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.
FDA device recall Z-0021-06 · posted 2005-10-07 · Terminated
Recall details
- Recalling firm
- Pioneer Surgical Technology
- Reason for recall
- Screw may be incorrectly etched as to length.
- Action taken
- Consignees were notified by letter dated 7/29/05 to inspect stocks in storage and at point of use locations hand for correct length and that a firm representative would visit them to pick up any mis-etched product.
- Root cause
- Other
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 124
- Distribution
- Nationwide.
- Date initiated
- 2005-07-29
- Date posted
- 2005-10-07
- Date terminated
- 2005-10-25
- 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 |
|---|---|---|
| PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM (K041167) | Pioneer Surgical Technology | 2004-07-23 |