FMS neXtra¿ 3 — Class II medical device recall Z-0656-2016
Terminated recall by DePuy Mitek, Inc., a Johnson & Johnson Co., reported 2016-01-27, distributed in ME, MI, OH, TX. Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on
| Recall number | Z-0656-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, United States |
| Recall initiated | 2015-11-20 |
| Classified | 2016-01-15 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2017-04-12 |
| Distributed | ME, MI, OH, TX |
| Quantity | 50 units |
| Reason classes | labeling |
| Lot numbers | M1505055 |
Product
FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Reason for recall
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
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-0656-2016. 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.