Recall Z-1457-05 ยท MVH Device, Detection, Sulfide
Pioneer Surgical Technology
Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.
| Date | Aug 31, 2005 (initiated Jul 29, 2005) |
| Status | Terminated |
| Reason | The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively. |
| Root cause | Other |
| Action | 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. |
| Quantity | 5069 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041156 | AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 Nonin Medical, Inc., Jun 9, 2004 |