Reported Jan 22, 2020 · Terminated
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Trilliant Surgical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Trilliant Surgical, LLC · 727 N Shepherd Dr Ste 100 · Houston, TX · 77007-1320
Is this the product you have?
- Gridlock Ankle Screw Driver
- Bit REF 320-35-003 - Product UsageA screwdriver facilitates implant insertion and removal
- Lot codes and dates
- Part Number320-35-003
- Lot NumberTSL006617
- UDI(01)00812926026893(10)TSL006617
- Amount recalled
- 20 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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