1.8mm Truss Wire, REF: 900217, a Component of Metalogix… recallZ-1236-2022 · New Standard Device Inc · initiated Jun 8, 2020
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from New Standard Device Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1236-2022
- Status
- Completed
- Initiated by the company
- Jun 8, 2020
- Recalling firm
- New Standard Device Inc
- Quantity
- 426
- Product code
- KTT
- FDA submissions
- K181630
- Distribution
- US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
Product description
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Code information (models, lots, serial numbers)
UDI: 854641008419, Lots: A29518X and A17219DA
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Revolution External Plating System 900217Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
Other devices under the same FDA submission
5 devices cleared under K181630 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Revolution External Plating System 900104Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
- Revolution External Plating System 620030Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
- Revolution External Plating System 620040Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
- Revolution External Plating System 620060Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
- Revolution External Plating System 620080Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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