Recall Z-2573-2014
Pioneer Surgical Technology, Inc. · initiated September 10, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
Codes / lots: Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.
Reason for recall
Some set screw thread profiles were found not to be within specifications.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2573-2014
- Initiated
- September 10, 2012
- Posted by FDA
- September 3, 2014
- Terminated
- September 30, 2014
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 11 sets
- Distribution
- Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.
- Recalling firm
- Pioneer Surgical Technology, Inc., Marquette, MI