Reported Aug 26, 2015 · Terminated
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part #…
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?
- 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002
- NON-STERILE Product UsageThe 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 numbers 1362-01 and 1364-01
- Amount recalled
- 102 units
Where it was sold
Why it was recalled
The cutting efficiency of the Countersinks was out of specification.
This product could cause temporary or reversible health problems — stop using it.
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