# FDA recall Z-1649-2022

> **New Standard Device Inc** · Class II · device recall initiated 2020-12-28.

## Product

Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic.        Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030    Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040      Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060      Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

## Reason for recall

Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

## Distribution

U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA  O.U.S.: None

## Key facts

- **Recall number:** Z-1649-2022
- **Recalling firm:** New Standard Device Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-28
- **Report date:** 2022-09-07

- **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-1649-2022

## Citation

> AI Analytics. FDA recall Z-1649-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1649-2022. Source: US FDA. Licensed CC0.

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