# FDA recall Z-2758-2026

> **Paragon 28, Inc.** · Class II · device recall initiated 2026-06-17.

## Product

P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.

## Reason for recall

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

## Distribution

US nationwide, Australia, Canada, The Netherlands, and New Zealand

## Key facts

- **Recall number:** Z-2758-2026
- **Recalling firm:** Paragon 28, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-17
- **Report date:** 2026-07-29

- **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-2758-2026

## Citation

> AI Analytics. FDA recall Z-2758-2026. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-2758-2026. Source: US FDA. Licensed CC0.

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