# FDA recall Z-2261-2018

> **Paragon 28, Inc.** · Class II · device recall initiated 2017-12-19.

## Product

P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

## Reason for recall

Missing drill guide as stated in the package.

## Distribution

Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.

## Key facts

- **Recall number:** Z-2261-2018
- **Recalling firm:** Paragon 28, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-19
- **Report date:** 2018-06-27
- **Termination date:** 2021-01-15

- **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-2261-2018

## Citation

> AI Analytics. FDA recall Z-2261-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2261-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*