Recall Z-2738-2015 ยท HRS Plate, Fixation, Bone
Trilliant Surgical Ltd.
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.
| Date | Sep 4, 2015 (initiated Jul 31, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | The firm sent out a written notification of the recall on 7/31/2015. |
| Quantity | 108 units |
| Distribution | NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121452 | GRIDLOCK PLATING SYSTEM Trilliant Surgical, Ltd., Aug 20, 2012 |