Reported Sep 2, 2015 · Terminated
3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation…
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?
- 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger 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 1363-01
- Amount recalled
- 121 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
Why it was recalled
The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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