# FDA recall Z-0125-2019

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-08-08.

## Product

Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320    Product Usage:  Intended for the fixation of fractures

## Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

## Distribution

Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.    The products were distributed to the following foreign countries:  Chile, Netherlands.

## Key facts

- **Recall number:** Z-0125-2019
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-08
- **Report date:** 2018-10-24
- **Termination date:** 2020-07-30

- **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-0125-2019

## Citation

> AI Analytics. FDA recall Z-0125-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0125-2019. Source: US FDA. Licensed CC0.

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