STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
FDA device recall Z-2573-2014 · posted 2014-09-03 · Terminated
Recall details
- Recalling firm
- PIONEER SURGICAL TECHNOLOGY, INC.
- Reason for recall
- Some set screw thread profiles were found not to be within specifications.
- Action taken
- The recall took place at the distributor/sales representative level. Communication was done through phone and email notifications on 9/10/2012. All affected set screws were to be traded out through a scheduled process. This was coordinated through Pioneer Surgical's customer service. Product was scrapped and no reconditioning took place. All affected set screws were swapped out.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 11 sets
- Distribution
- Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.
- Date initiated
- 2012-09-10
- Date posted
- 2014-09-03
- Date terminated
- 2014-09-30
- Location
- Marquette, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PIONEER POSTERIOR CERVICO THORACIC SYSTEM (K112757) | Pioneer Surgical Technology, Inc. | 2012-03-12 |