Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is
FDA device recall Z-2616-2014 · posted 2014-09-09 · Terminated
Recall details
- Recalling firm
- PIONEER SURGICAL TECHNOLOGY, INC.
- Reason for recall
- The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 9
- Distribution
- Nationwide Distribution including TX, CA, IL, and FL.
- Date initiated
- 2013-06-14
- Date posted
- 2014-09-09
- Date terminated
- 2014-09-30
- Location
- Marquette, MI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STREAMLINE MIS SPINAL FIXATION SYSTEM (K130286) | Pioneer Surgical Technology, Inc. | 2013-04-01 |