Trilliant Gridlock Ankle Screw Driver Bit Recalled for Specification Defect
Trilliant Surgical is recalling 20 Gridlock Ankle Screw Driver Bits because they are out of specification and may fail to retain screws during implant procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences or significant injury/property damage reports are assigned a score of 4 (Severe).
Plain-English summary
Trilliant Surgical, LLC is recalling 20 units of the Gridlock Ankle Screw Driver Bit (REF 320-35-003). The recall was initiated because the screwdriver bits were found to be out of specification for the minor diameter of the drive feature. This defect causes the driver to be unable to retain screws as intended during the insertion and removal of implants.
The affected units are identified by Part Number 320-35-003 and Lot Number TSL006617. The UDI for the product is (01)00812926026893(10)TSL006617. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The product was distributed nationwide in the United States, specifically in the states of Colorado, Connecticut, Iowa, Texas, and Wisconsin. No distribution outside the United States is reported. Healthcare providers and facilities should stop using the affected screwdriver bits and contact Trilliant Surgical for further instructions on the recall.
The recalled product
- Product
- Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
- Manufacturer
- Trilliant Surgical, LLC
- Affected units
- 20
Distribution
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