Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Check against the official notice below — it lists the full affected range.
Trilliant Surgical, LLC is recalling the Gridlock Ankle Screw Driver Bit (Part Number 320-35-003, Lot Number TSL006617) because the screwdriver's drive feature has an out-of-specification minor diameter that prevents it from properly retaining screws during implant insertion and removal procedures. Twenty units were distributed nationwide in Colorado, Connecticut, Iowa, Texas, and Wisconsin.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended.
Reason for recall: A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended. Distribution: US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None Quantity: 20 units Lot/code info: Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.