# FDA recall Z-0399-2019

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-09-21.

## Product

StageOne Hip, Models 431207 & 431209Usage:      Product Usage:  The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a dispenser/gun into the mold. After the cement cures, the temporary spacers are to be removed from the molds with the reinforcement remaining as the core of the spacer, and placed into the joint space. The spacers remain in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.

## Reason for recall

There is a potential for comingling of the 43MM and 51 MM molds

## Distribution

US Nationwide Distribution in the states of:  AZ, FL, MI, OH, VA & WI

## Key facts

- **Recall number:** Z-0399-2019
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-21
- **Report date:** 2018-11-14
- **Termination date:** 2020-04-14

- **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-0399-2019

## Citation

> AI Analytics. FDA recall Z-0399-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0399-2019. Source: US FDA. Licensed CC0.

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