Trilliant Surgical recalls Gridlock Ankle Screw Driver Bit REF 320-35-003 due to potential failure to retain screws during implant procedures. Affected units include specific lot numbers and part numbers.
A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended.
Trilliant Surgical is recalling a specific ankle screw driver bit because it may not hold screws properly during surgical procedures. This could lead to improper implant insertion or removal if the bit fails to retain screws as intended.
The screwdriver bit may not retain screws properly due to being out of specification for the minor diameter of the drive feature. This could lead to screws loosening during implant insertion or removal, potentially causing procedural complications.
Surgical professionals using the Gridlock Ankle Screw Driver Bit REF 320-35-003 for implant procedures are affected. The risk is low as the hazard relates to a minor diameter issue that may not cause serious injury in normal use.
Check for the part number 320-35-003 and lot number TSL006617 on the product. The recall applies to the Gridlock Ankle Screw Driver Bit used in surgical implant procedures.
Verify the part number 320-35-003 and lot number TSL006617 on the product.
The recall indicates the bit may not retain screws properly, but the hazard is low risk as it relates to a minor diameter issue that does not typically cause serious injury.
The recall does not specify a remedy, so no action is required beyond checking the product details for the part number and lot number.
Check for the part number 320-35-003 and lot number TSL006617 on the product.
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0799-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-0799-2020 from Trilliant Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
