Home / Recalls / New Standard Device Inc / Z-1236-2022

Z-1236-2022 Class II

Recalled by New Standard Device Inc — San Antonio, TX

Recall Details

Product Type
Devices
Report Date
June 15, 2022
Initiation Date
June 8, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
426

Product Description

1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

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 Pattern

US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.

Code Information

UDI: 854641008419, Lots: A29518X and A17219DA

Other recalls by New Standard Device Inc

  • Z-1649-2022 Class II — Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation S (December 28, 2020)
  • Z-1280-2022 Class II — Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A (August 14, 2019)
  • Z-1824-2023 Class II — 'n'-Hole Post which is a component of the Revolution External Fixation System (July 23, 2019)