New Standard Device Inc 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Brand
New Standard Device Inc
Lot Codes / Batch Numbers
UDI: 854641008419, Lots: A29518X and A17219DA
Products Sold
UDI: 854641008419, Lots: A29518X and A17219DA
New Standard Device Inc is recalling 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026