FDA recall Z-1236-2022

New Standard Device Inc · Class II · device

Product

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

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

Key facts

Status
Completed
Initiation date
2020-06-08
Report date
2022-06-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Antonio, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1236-2022