Reported Jan 18, 2017 · Terminated

Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system…

Trilliant Surgical Ltd.

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 Ltd. · 6721 Portwest Dr Ste 160 · Houston, TX · 77024-8019

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot
    • TSL003191
    • TSL003637
    • TSL004101
    • TSL004395
Amount recalled
50 units

Where it was sold

  • Nationwide

Why it was recalled

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.

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 May 17, 2017 · Data as of Sep 19, 6:51 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.