# FDA recall Z-1644-2020

> **Biomet, Inc.** · Class II · device recall initiated 2020-02-26.

## Product

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

## Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

## Distribution

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

## Key facts

- **Recall number:** Z-1644-2020
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-26
- **Report date:** 2020-04-15
- **Termination date:** 2021-07-29

- **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-1644-2020

## Citation

> AI Analytics. FDA recall Z-1644-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1644-2020. Source: US FDA. Licensed CC0.

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