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
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1236-2022 |
| Event ID | 90133 |
| Event Description | 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA. |
| Quantity | 426 |
| Recall 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. |
| Device Classification | 20220615 |
| Device Code Info | UDI: 854641008419, Lots: A29518X and A17219DA |
| Center Classification Date | 20220603 |
| Recall Initiation Date | 20200608 |
| Recalling Firm | New Standard Device Inc |
| Initial Notification | Letter |
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