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Recall Observatory FDA recall evidence

Device product

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

Z-1236-2022

June 08, 2020

Class II

Product summary

Firm
New Standard Device Inc
Event
Event 90133
Status
Completed
Classification
Class II
Quantity
426
Official record key
device-enforcement:Z-1236-2022

Official wording

Reason: 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.

Code information: UDI: 854641008419, Lots: A29518X and A17219DA

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.