RecallRadar

FDA Device recall Z-1236-2022

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

On 2022-06-15 the FDA classified a Class II recall of 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System by New Standard Device, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1236-2022
ClassificationClass II
Statuscompleted
Initiated2020-06-08
Published2022-06-15
Last updated2026-09-13 11:56 UTC
CompanyNew Standard Device
DistributionUS

Product

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

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.

Identifiers

code_infoUDI: 854641008419, Lots: A29518X and A17219DA

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1236-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.