Reported Jun 15, 2022 · Completed

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

New Standard Device Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: New Standard Device Inc · 4848 Research Dr · San Antonio, TX · 78240-5005

Is this the product you have?

  • 1.8mm Truss Wire
  • REF900217, a Component of Metalogix Revolution External Plating System
Lot codes and dates
  • UDI854641008419
  • LotsA29518X and A17219DA
Amount recalled
426

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.