Recall Z-2738-2015— Trilliant Surgical Ltd.
Class II · Terminated
Class II FDA medical device recall by Trilliant Surgical Ltd., initiated 2015-07-31, terminated 2017-01-26. It names one FDA 510(k) clearance: K121452. Product: 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.. 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..
- Recalling firm
- Trilliant Surgical Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-31
- Terminated
- 2017-01-26
- Firm location
- Houston, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.