Synthes Titanium Midface Distractor — Class II medical device recall Z-0942-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-03-20, distributed in CA, LA, MA, NY, PA. There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as
| Recall number | Z-0942-2013 |
|---|---|
| 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 | 2013-01-11 |
| Classified | 2013-03-11 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2015-08-31 |
| Distributed | CA, LA, MA, NY, PA |
| Countries outside the US | CA, CH |
| Quantity | 596 |
| Model numbers | 487.982 |
Product
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Reason for recall
There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.
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-0942-2013. 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.