# FDA recall Z-1255-2024

> **Paragon 28, Inc.** · Class II · device recall initiated 2023-12-21.

## Product

Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L

## Reason for recall

Medical devices distributed, prior to sterilization

## Distribution

US:CA OUS: None

## Key facts

- **Recall number:** Z-1255-2024
- **Recalling firm:** Paragon 28, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-21
- **Report date:** 2024-03-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Englewood, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1255-2024

## Citation

> AI Analytics. FDA recall Z-1255-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1255-2024. Source: US FDA. Licensed CC0.

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