Recall Z-0799-2020— Trilliant Surgical, LLC
Class II · Terminated
Class II FDA medical device recall by Trilliant Surgical, LLC, initiated 2019-03-14, terminated 2022-03-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.. Reason: 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..
- Recalling firm
- Trilliant Surgical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-14
- Terminated
- 2022-03-16
- Firm location
- Houston, TX, United States
Product description
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.