New Standard Device Inc recalls 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

Recall date

June 8, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1236-2022

FDA classification

Class II

Brand / firm

New Standard Device Inc

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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