Synthes Flexible Shaft — Class II medical device recall Z-0656-2017
Terminated recall by Synthes (USA) Products LLC, reported 2016-11-30, distributed nationwide. Non-conforming material used.
| Recall number | Z-0656-2017 |
|---|---|
| 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 | 2016-10-31 |
| Classified | 2016-11-23 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 198 units |
| Lot numbers | 9916503, 9916508, 9947895, L000158, L000160, L000573, L000603, L000604, L000605, L000607, L000632, L082974, L084498 |
| Model numbers | 352.040, 352.044 |
Product
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
Reason for recall
Non-conforming material used.
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-0656-2017. 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.