# FDA recall Z-0448-2019

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-10-02.

## Product

Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300     The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.

## Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

## Distribution

Worldwide Distribution: US (nationwide) to states of:  AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and  foreign countries of:  Chile, Costa Rica, Ecuador and Netherlands.

## Key facts

- **Recall number:** Z-0448-2019
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-02
- **Report date:** 2018-11-21
- **Termination date:** 2020-06-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0448-2019

## Citation

> AI Analytics. FDA recall Z-0448-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0448-2019. Source: US FDA. Licensed CC0.

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