# FDA recall Z-1963-2019

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2019-06-04.

## Product

Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.

## Reason for recall

The products do not have sufficient data to support the labeled shelf life of 10 years.

## Distribution

Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.

## Key facts

- **Recall number:** Z-1963-2019
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-04
- **Report date:** 2019-07-24
- **Termination date:** 2021-07-21

- **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-1963-2019

## Citation

> AI Analytics. FDA recall Z-1963-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1963-2019. Source: US FDA. Licensed CC0.

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