Synthes — Class II medical device recall Z-0781-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-02-13, distributed nationwide. Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit res
| Recall number | Z-0781-2013 |
|---|---|
| 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 | 2012-08-06 |
| Classified | 2013-02-04 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2015-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 63 |
| Lot numbers | 5443576, 5522810, 5537042, 5557902 |
| Model numbers | 03.613.011, 5443576, 5522810, 5537042, 5557902 |
Product
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Reason for recall
Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
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-0781-2013. 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.