Product Safety Recalls

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New Standard Device Inc Recall 90133

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

New Standard Device Inc Recall 90133 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-1236-2022
Event ID90133
Event Description1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Product TypeDevices
DistributionUS Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
Quantity426
Recall Reason1.8mm 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.
Device Classification20220615
Device Code InfoUDI: 854641008419, Lots: A29518X and A17219DA
Center Classification Date20220603
Recall Initiation Date20200608
Recalling FirmNew Standard Device Inc
Initial Notification Letter
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