BIOMET StageOne Hip Cement Spacer Mold with Insert recalled over mold contamination
- Recall date
- February 26, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Biomet, Inc. recalls BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
- Recall number
- Z-1641-2020
- FDA classification
- Class II
- Brand / firm
- Biomet, Inc.
- Sold / distributed
- 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, Mis…
Why it was recalled
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
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