Synthes Hand Switch — Class II medical device recall Z-0615-2014
Terminated recall by Synthes USA HQ, Inc., reported 2014-01-08, distributed nationwide. Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not label
| Recall number | Z-0615-2014 |
|---|---|
| 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 | 2013-04-15 |
| Classified | 2013-12-31 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2016-09-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 290 |
| Reason classes | labeling |
| Lot numbers | AV18166 |
| Model numbers | 05.001.012 |
Product
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.
Reason for recall
Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.
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-0615-2014. 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.