Trilliant Surgical Recalls 3.0/4.0 Cannulated Drill Bits Due to Sizing Issue
Trilliant Surgical Ltd. is recalling 121 units of 3.0/4.0 Cannulated Drill Bits because the inner diameter is too small for the guide wire to pass through.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a functional sizing issue that prevents proper use of the device. No injuries, illnesses, or deaths are reported in the source text, and the hazard is theoretical rather than a high-risk pathogen or structural failure causing immediate harm.
Plain-English summary
Trilliant Surgical Ltd. is recalling 121 units of the 3.0/4.0 Cannulated Drill Bit, a component of the Tiger Cannulated Screw System. The recall is due to a manufacturing defect where the inner diameter of the drill bit is too small to allow the guide wire to pass completely through.
The Tiger Cannulated Screw Fixation System implants are intended for the 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.
The affected units were distributed nationwide, including in New York, Texas, Ohio, Indiana, Florida, New Hampshire, Minnesota, South Carolina, Oklahoma, New Jersey, California, North Carolina, Missouri, Georgia, Wisconsin, Iowa, Tennessee, Washington, and Puerto Rico. The specific lot number is 1363-01. Healthcare providers should stop using these drill bits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 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 wire
- Manufacturer
- Trilliant Surgical Ltd.
- Hazard
- Affected units
- 121
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 1363-01
Distribution
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