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
FDA device recall Z-2738-2015 · posted 2015-09-04 · Terminated
Recall details
- Recalling firm
- Trilliant Surgical Ltd.
- 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.
- Action taken
- The firm sent out a written notification of the recall on 7/31/2015.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 108 units
- Distribution
- NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX
- Date initiated
- 2015-07-31
- Date posted
- 2015-09-04
- Date terminated
- 2017-01-26
- Location
- Houston, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRIDLOCK PLATING SYSTEM (K121452) | Trilliant Surgical, Ltd. | 2012-08-20 |