Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a com...
FDA Recall #Z-0960-2017 — Class II — December 8, 2016
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.
Recalling Firm
Trilliant Surgical Ltd. — Houston, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
50 units
Distribution
Nationwide Distribution
Code Information
Lot: TSL003191, TSL003637, TSL004101, TSL004395
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated