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.
FDA Recall Z-2738-2015 · Posted 2015-09-04
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Recalling FirmTrilliant Surgical Ltd.
Recall StatusTerminated
Product CodeHRS
Date Initiated2015-07-31
Date Terminated2017-01-26
Product Quantity108 units
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.
Firm Action
The firm sent out a written notification of the recall on 7/31/2015.
Root Cause
Component design/selection
Distribution Pattern
NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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