Synthes Matrix Threaded Persuader Deformity is a recall
Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical…
Why was Synthes Matrix Threaded Persuader Deformity is a recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Lot Number Number 03.632.008 4833901 03.632.008 6284014 03.632.008 6284015 03.632.008 6377412 03.632.008 6390270 03.632.008 6390308 03.632.008 6390309 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6558995 03.632.008 6559002 03.632.008 6583188 03.632.008 6583189 03.632.008 6603334 03.632.008 6603335 03.632.008 6624550 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635 03.632.008 4833901 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6603334 03.632.008 6603335 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635
- Product
- Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical…
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 634
- Distribution
- Worldwide distribution: US (nationwide) and countries of Canada and Switzerland.
- Recall date
- December 4, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)