Synthes Matrix Threaded Persuader Deformity is a comprehensive… — Class II medical device recall Z-0384-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-04, distributed nationwide. Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunc
| Recall number | Z-0384-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-07-31 |
| Classified | 2013-11-22 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH |
| Quantity | 634 |
| Reason classes | device malfunction |
| Lot numbers | 03.632.008, 4833901, 6284014, 6284015, 6377412, 6390270, 6390308, 6390309, 6445711, 6455761, 6455786, 6530998, 6548747, 6558995, 6559002, 6583188, 6583189, 6603334, 6603335, 6624550, 6676663, 6703414, 6706733, 6718634, 6718635 |
| Model numbers | 03.632.008, 4833901, 6284014, 6284015, 6377412, 6390270, 6390308, 6390309, 6445711, 6455761, 6455786, 6530998, 6548747, 6558995, 6559002, 6583188, 6583189, 6603334, 6603335, 6624550, 6676663, 6703414, 6706733, 6718634, 6718635 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0384-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.