# FDA recall Z-1824-2023

> **New Standard Device Inc** · Class II · device recall initiated 2019-07-23.

## Product

'n'-Hole Post which is a component of the Revolution External Fixation System    Catalog Numbers:  100801,  100802,  100803,  100804,  100805

## Reason for recall

The threads on posts stripping out when tensioned during application process.

## Distribution

U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.

## Key facts

- **Recall number:** Z-1824-2023
- **Recalling firm:** New Standard Device Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-07-23
- **Report date:** 2023-06-21

- **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-1824-2023

## Citation

> AI Analytics. FDA recall Z-1824-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1824-2023. Source: US FDA. Licensed CC0.

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