New Standard Device Inc: Medical Device Recall in 2022 - (Recall #: Z-1236-2022)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2022.
Data Source: FDA.
Product Description:
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Product Classification:
Class II
Date Initiated: June 8, 2020
Date Posted: June 15, 2022
Recall Number: Z-1236-2022
Event ID: 90133
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.
Status: Completed
Product Quantity: 426
Code Information:
UDI: 854641008419, Lots: A29518X and A17219DA
Distribution Pattern:
US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
Voluntary or Mandated:
Voluntary: Firm initiated