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Completed

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

FDA Recall Z-1236-2022 · Posted None

Recalling FirmNew Standard Device Inc
Recall StatusCompleted
Product CodeKTT
Date Initiated2020-06-08
Product Quantity426

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.

Firm Action

On 06/08/2020, Market Withdrawal notices were emailed to customers who were asked to remove affected truss wires from inventory and return to the recalling firm. Customers were informed to use alternate 1.8mm and 2.0mm unaffected smooth wires. Upon completion of verification testing, both 2.0mm truss and smooth wires will be released for use. Customers with additional questions are encouraged to call (833) 659-2019 Ext 6.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181630Revolution External Plating SystemNew Standard Device Dba Metalogix · 2019-05-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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