Recall Z-2573-2014 ยท KWP Appliance, Fixation, Spinal Interlaminal
PIONEER SURGICAL TECHNOLOGY, INC.
STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
| Date | Sep 3, 2014 (initiated Sep 10, 2012) |
| Status | Terminated |
| Reason | Some set screw thread profiles were found not to be within specifications. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 11 sets |
| Distribution | Distributed in the states of NC, NH, NY, CA, MI, IL, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112757 | PIONEER POSTERIOR CERVICO THORACIC SYSTEM Pioneer Surgical Technology, Inc., Mar 12, 2012 |