Synthes Matrix 5 — Class II medical device recall Z-0391-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-04, distributed nationwide. A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending
| Recall number | Z-0391-2014 |
|---|---|
| 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 | 2013-06-22 |
| Classified | 2013-11-25 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-09-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 209 |
| Lot numbers | 03.632.040, 03.632.041, T935338, T935343, T939100, T939105, T939755, T945062, T945067, T952750, T953982, T956310, T956315, T959990, T959995, T960000, T960005 |
| Model numbers | 03.632.040, 03.632.041, T935338, T935343, T939100, T939105, T939755, T945062, T945067, T952750, T953982, T956310, T956315, T959990, T959995, T960000, T960005 |
Product
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.
Reason for recall
A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.
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-0391-2014. 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.