FDA Device recall Z-0384-2014
Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechan…
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechan… by Synthes Usa Hq, citing 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 R….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0384-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-31 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
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.
Identifiers
| code_info | Item Lot Number Number 03.632.008 4833901 03.632.008 6284014 03.632.008 6284015 03.632.008 6377412 03.632.008 639…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0384-2014%22
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