FDA Device recall Z-0658-2016
FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades
- FDA Device
- Class II
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class II recall of FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades by Depuy Mitek A Johnson And Johnson, citing product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0658-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-20 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Depuy Mitek A Johnson And Johnson |
| Distribution | DE, ME, MI, OH, TX |
Product
FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Reason
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Identifiers
| code_info | Lot Number: M1505056 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0658-2016%22
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