Z-0656-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2016
- Initiation Date
- November 20, 2015
- Termination Date
- April 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
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.
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: M1505055