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.
This recall has been terminated (originally issued September 4, 2015).
- Company
- Trilliant Surgical Ltd.
- Recall Initiated
- July 31, 2015
- Posted
- September 4, 2015
- Terminated
- January 26, 2017
- Recall Number
- Z-2738-2015
- Quantity
- 108 units
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively. Specifically, the minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head.
Distribution
NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX
Lot / Code Info
TSL002605
Root Cause
Component design/selection
Action Taken
The firm sent out a written notification of the recall on 7/31/2015.
More recalls by Trilliant Surgical Ltd.
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O
The product is a compone...
Jan 6, 2017