Reported Sep 2, 2015 · Terminated

Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE;…

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?

3 of 3 products

Products covered by this recall
Model / numberProduct as published
210-00-001-1Tiger Cannulated Tray Lid NON-STERILE
210-99-101Combined Tiger/Headless Screw NON-STERILE
These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
Lot codes and dates
  • Lot Numbers ALU120514552473 and 45479
Amount recalled
71 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.

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 Jan 26, 2017 · Data as of Sep 19, 6:14 PM UTC

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