# FDA recall Z-1236-2022

> **New Standard Device Inc** · Class II · device recall initiated 2020-06-08.

## 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.

## Distribution

US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.

## Key facts

- **Recall number:** Z-1236-2022
- **Recalling firm:** New Standard Device Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2020-06-08
- **Report date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Antonio, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1236-2022

## Citation

> AI Analytics. FDA recall Z-1236-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1236-2022. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
