FDAFDA · Food and drugs·Recall number Z-1236-2022
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Published June 15, 2022 · Recall initiated: June 8, 2020
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- New Standard Device Inc
- Distributor
- US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
- Lot
- UDI: 854641008419, Lots: A29518X and A17219DA
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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