# FDA recall Z-0918-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-10-03.

## Product

Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04

## Reason for recall

The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications.

## Distribution

Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.

## Key facts

- **Recall number:** Z-0918-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-03
- **Report date:** 2018-03-14
- **Termination date:** 2018-08-20

- **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-0918-2018

## Citation

> AI Analytics. FDA recall Z-0918-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0918-2018. Source: US FDA. Licensed CC0.

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