# FDA recall Z-0871-2026

> **Paragon 28, Inc.** · Class II · device recall initiated 2025-10-13.

## Product

Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

## Reason for recall

Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.

## Distribution

US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.

## Key facts

- **Recall number:** Z-0871-2026
- **Recalling firm:** Paragon 28, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-13
- **Report date:** 2025-12-10

- **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-0871-2026

## Citation

> AI Analytics. FDA recall Z-0871-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0871-2026. Source: US FDA. Licensed CC0.

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