Recall Z-2616-2014 ยท NKB Thoracolumbosacral Pedicle Screw System
PIONEER SURGICAL TECHNOLOGY, INC.
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined
| Date | Sep 9, 2014 (initiated Jun 14, 2013) |
| Status | Terminated |
| Reason | The affected fixed rod holders did not allow the instrument to lock down on the spinal rod. |
| Root cause | Device Design |
| Action | Pioneer Surgical sent a Product Field Action letter on July 7, 2013, to all affected customers. The letter described the affected product and issue, and provided instructions for return of the recalled product. All 9 affected instruments were returned to Pioneer Surgical, reconditioned and sent back to the field. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812. |
| Quantity | 9 |
| Distribution | Nationwide Distribution including TX, CA, IL, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130286 | STREAMLINE MIS SPINAL FIXATION SYSTEM Pioneer Surgical Technology, Inc., Apr 1, 2013 |