Synthes CMF Distraction System The product is intended for use as a… — Class II medical device recall Z-1726-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-07-24, distributed nationwide. The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF)
| Recall number | Z-1726-2013 |
|---|---|
| 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 | 2013-06-12 |
| Classified | 2013-07-12 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2015-09-21 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Lot numbers | 22612-04, 6184270 |
| Model numbers | 04.315.067 |
Product
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
Reason for recall
The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.
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-1726-2013. 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.