Z-2738-2015 Class II Terminated
FDA device recall Z-2738-2015 was initiated by Trilliant Surgical Ltd. on July 31, 2015 and is designated Class II. 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 in… The recall status is terminated (terminated January 26, 2017). Affected quantity: 108 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2015
- Initiation Date
- July 31, 2015
- Termination Date
- January 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 108 units
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.
Distribution Pattern
NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX
Code Information
TSL002605