Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.
FDA device recall Z-1457-05 · posted 2005-08-31 · Terminated
Recall details
- Recalling firm
- Pioneer Surgical Technology
- Reason for recall
- The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.
- Action taken
- Distributors were notified via letter dated July 29, 2005 to retrieve all caps from inventory and point of use locations and to return them to Pioneer.
- Root cause
- Other
- Status
- Terminated
- Product code
- MVH
- Quantity affected
- 5069
- Distribution
- Nationwide.
- Date initiated
- 2005-07-29
- Date posted
- 2005-08-31
- Date terminated
- 2005-10-25
- Location
- Marquette, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 (K041156) | Nonin Medical, Inc. | 2004-06-09 |