Recall Z-0021-06 ยท NKB Thoracolumbosacral Pedicle Screw System
Pioneer Surgical Technology
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.
| Date | Oct 7, 2005 (initiated Jul 29, 2005) |
| Status | Terminated |
| Reason | Screw may be incorrectly etched as to length. |
| Root cause | Other |
| Action | 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. |
| Quantity | 124 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041167 | PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM Pioneer Surgical Technology, Jul 23, 2004 |