FDA Device recall Z-1236-2022
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
- FDA Device
- Class II
- completed
- Published 2022-06-15
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-1236-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-06-08 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | New Standard Device |
| Distribution | US |
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_info | UDI: 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
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