Zimmer Biomet, Inc. recalls Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provi…
- Recall date
- June 4, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1962-2019
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.
Why it was recalled
The products do not have sufficient data to support the labeled shelf life of 10 years.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - 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.
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