Recall Z-0384-2014— Synthes USA HQ, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-07-31, terminated 2015-08-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.. Reason: Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required..
- Recalling firm
- Synthes USA HQ, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-31
- Terminated
- 2015-08-31
- Firm location
- West Chester, PA, United States
Product description
Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.
Reason for recall
Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required.
Data sourced from openFDA. This site is unofficial and independent of the FDA.