| Class 2 Device Recall 1.8mm Truss Wire | |
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
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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
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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.
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Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = KTT
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