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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 16, 2022 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.