Synthes Small Electric Drive — Class II medical device recall Z-0931-2015
Terminated recall by Synthes (USA) Products LLC, reported 2015-01-14, distributed nationwide. The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or uni
| Recall number | Z-0931-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2014-11-06 |
| Classified | 2015-01-07 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 12 |
| Lot numbers | 105, 107, 111, 112, 113, 115 |
| Model numbers | 05.001.175 |
Product
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue.
Reason for recall
The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. Injuries may need surgical or medical intervention. Surgical delay and postoperative local infection are also potential risks.
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-0931-2015. 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.