Device product
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.
Z-0960-2017
Product summary
- Event
- Event 76029
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-0960-2017
Official wording
Reason: 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.
Code information: Lot: TSL003191, TSL003637, TSL004101, TSL004395
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.