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U.S. Department of Health and Human Services

Class 2 Device Recall Gridlock Screw Driver Bit

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 Class 2 Device Recall Gridlock Screw Driver Bitsee related information
Date Initiated by FirmJuly 31, 2015
Date PostedSeptember 04, 2015
Recall Status1 Terminated 3 on January 26, 2017
Recall NumberZ-2738-2015
Recall Event ID 71936
510(K)NumberK121452 
Product Classification Plate, fixation, bone - Product Code HRS
Product2.4, 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.
Code Information TSL002605
Recalling Firm/
Manufacturer		 Trilliant Surgical Ltd.
6721 Portwest Dr Ste 160
Houston TX 77024-8019
For Additional Information ContactScott Bishop
800-495-2919
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionThe firm sent out a written notification of the recall on 7/31/2015.
Quantity in Commerce108 units
DistributionNY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HRS
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