Z-0960-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2017
- Initiation Date
- December 8, 2016
- Termination Date
- May 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Reason for Recall
Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
Distribution Pattern
Nationwide Distribution
Code Information
Lot: TSL003191, TSL003637, TSL004101, TSL004395