Z-1236-2022 Class II
FDA device recall Z-1236-2022 was initiated by New Standard Device Inc on June 8, 2020 and is designated Class II. 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 brea… Affected quantity: 426.
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2022
- Initiation Date
- June 8, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 426
Product Description
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 Pattern
US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
Code Information
UDI: 854641008419, Lots: A29518X and A17219DA