Synthes Small Electric Drive — Class II medical device recall Z-0747-2016
Terminated recall by The Anspach Effort, Inc., reported 2016-02-10, distributed nationwide. The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when i
| Recall number | Z-0747-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Anspach Effort, Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2014-08-14 |
| Classified | 2016-02-03 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2016-02-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CL, CN, DE, DK, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, KR, MY, NL, NO, NZ, PL, RU, SE, SG, TH, TR, TW |
| Quantity | 599 units |
Product
Synthes Small Electric Drive (SED). For use in general traumatology.
Reason for recall
The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
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-0747-2016. 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.