Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Reported: January 22, 2020 Initiated: March 14, 2019 #Z-0799-2020
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.
Details
- Recalling Firm
- Trilliant Surgical, LLC
- Units Affected
- 20 units
- Distribution
- US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.. Recalled by Trilliant Surgical, LLC. Units affected: 20 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2020. Severity: Moderate. Recall number: Z-0799-2020.
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