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U.S. Department of Health and Human Services

Class 2 Device Recall 1.8mm Truss Wire

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  Class 2 Device Recall 1.8mm Truss Wire see related information
Date Initiated by Firm June 08, 2020
Create Date June 03, 2022
Recall Status1 Completed
Recall Number Z-1236-2022
Recall Event ID 90133
510(K)Number K181630  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Code Information UDI: 854641008419, Lots: A29518X and A17219DA
Recalling Firm/
Manufacturer		 New Standard Device Inc
4848 Research Dr
San Antonio TX 78240-5005
Manufacturer Reason
for Recall		 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.
FDA Determined
Cause 2		 Device Design
Action On 06/08/2020, Market Withdrawal notices were emailed to customers who were asked to remove affected truss wires from inventory and return to the recalling firm. Customers were informed to use alternate 1.8mm and 2.0mm unaffected smooth wires. Upon completion of verification testing, both 2.0mm truss and smooth wires will be released for use. Customers with additional questions are encouraged to call (833) 659-2019 Ext 6.
Quantity in Commerce 426
Distribution US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
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.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = New Standard Device DBA Metalogix
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