Recall Z-0291-2008 ยท HWR Driver, Prosthesis
Pioneer Surgical Technology
Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855
| Date | Nov 27, 2007 (initiated Oct 10, 2007) |
| Status | Terminated |
| Reason | The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient. |
| Root cause | Component change control |
| Action | Consignees were notified via a Product Recall letter dated 10/10/07 to remove these instruments from their instrument cases and to return them to the firm. |
| Quantity | 38 |
| Distribution | Nationwide: including states of California, Florida, Michigan and North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.