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