Synthes Multi-Vector Distractor — Class II medical device recall Z-0905-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-03-13, distributed nationwide. It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product speci
| Recall number | Z-0905-2013 |
|---|---|
| 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 | 2013-03-01 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2015-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 18 |
| Lot numbers | 3794466, 3800758, 3808876, 3817116, 7824423, 7883454 |
| Model numbers | 487.967 |
Product
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Reason for recall
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
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-0905-2013. 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.