Z-0658-2016 Class II Terminated
FDA device recall Z-0658-2016 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Nov 20, 2015 and is designated Class II. Reason for recall: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. The recall status is terminated (terminated Apr 12, 2017). Affected quantity: 115 units.
Recall details
- Product Type
- Devices
- Report Date
- Jan 27, 2016
- Initiation Date
- Nov 20, 2015
- Termination Date
- Apr 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115 units
Product description
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 for recall
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Distribution pattern
Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
Code information
Lot Number: M1505056
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0658-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026