1 — Class II medical device recall Z-1236-2022
Completed recall by New Standard Device Inc, reported 2022-06-15, distributed nationwide. 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire di
| Recall number | Z-1236-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | New Standard Device Inc, San Antonio, TX, United States |
| Recall initiated | 2020-06-08 |
| Classified | 2022-06-03 |
| Reported by FDA | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 426 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00854641008419 |
| Lot numbers | A17219DA, A29518X |
| Model numbers | 900217 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1236-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.