1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
- Company
- New Standard Device Inc
- Recall Initiated
- June 8, 2020
- Recall Number
- Z-1236-2022
- Quantity
- 426
- Firm Location
- San Antonio, TX
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.
Distribution
US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
Lot / Code Info
UDI: 854641008419, Lots: A29518X and A17219DA
Root Cause
Device Design
Action Taken
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.