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U.S. Department of Health and Human Services

Class 2 Device Recall Gridlock Ankle Screw Driver Bit

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  Class 2 Device Recall Gridlock Ankle Screw Driver Bit see related information
Date Initiated by Firm March 14, 2019
Create Date January 10, 2020
Recall Status1 Terminated 3 on March 16, 2022
Recall Number Z-0799-2020
Recall Event ID 84350
Product Classification Screwdriver - Product Code HXX
Product Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Code Information Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617
Recalling Firm/
Manufacturer		 Trilliant Surgical, LLC
727 N Shepherd Dr Ste 100
Houston TX 77007-1320
For Additional Information Contact Jodie Rodriguez
800-495-2919
Manufacturer Reason
for Recall		 A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended.
FDA Determined
Cause 2		 Process control
Action The recall strategy included sending written recall communication and response forms as of 03/14/2019 via FedEx (Express Standard Overnight) to all consignees that showed possession / had been sold a device (as the device is considered reusable) as of 03/14/2019. The communication instructed the consignees to: " Check inventory stock for identified devices " Locate and remove and/or discontinue use of identified devices " Return all related product(s) to Recalling Firm in accordance with the included return response / acknowledgement form.
Quantity in Commerce 20 units
Distribution US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
Total Product Life Cycle TPLC 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.
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