Trilliant Gridlock Screw Driver Bits Recalled for Out-of-Specification Dimensions
Trilliant Surgical Ltd. is recalling 108 units of Gridlock Screw Driver Bits because they are out of specification, which may cause screw heads to strip during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (stripping screw heads) during a medical procedure, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Trilliant Surgical Ltd. is recalling 108 units of 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bits, Model Number 310-30-003, Lot Number TSL002605. These non-sterile medical devices are intended for use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.
The recall was initiated because the screw driver bits were identified to be out of specification. Specifically, the minor diameter of the drive feature is above the specification, which potentially reduces the engagement between the driver and the screw head. This defect has the potential for shallow engagement, resulting in an increased likelihood of stripping screw heads intraoperatively.
The affected units were distributed to facilities in New York, Ohio, California, South Carolina, New Jersey, Arizona, Virginia, Indiana, Florida, Minnesota, Oklahoma, Arkansas, Missouri, Wisconsin, Georgia, South Dakota, Iowa, Illinois, and Texas. Healthcare facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.
- Manufacturer
- Trilliant Surgical Ltd.
- Affected units
- 108
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)
- TSL002605
Distribution
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