The Synthes Mandible External Fixator — Class II medical device recall Z-1009-2015
Terminated recall by Synthes, Inc., reported 2015-02-04. Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designate
| Recall number | Z-1009-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-10-17 |
| Classified | 2015-01-23 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2016-08-18 |
| Quantity | 43,159 |
| Reason classes | labeling |
| Model numbers | 03.305.006, 03.305.105, 03.305.500, 03.305.500S, 04.305.003, 04.305.004, 04.305.005, 04.305.010, 04.305.011, 04.305.012, 04.305.100, 04.305.101, 04.305.102, 04.305.103, 04.305.128, 04.305.130, 04.305.134, 04.305.138, 04.305.140, 04.305.142 |
Product
The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105 03.305.500 03.305.500S Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Reason for recall
Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.
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-1009-2015. 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.