Howmedica Osteonics Corp. recalls MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
- Recall date
- August 7, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0044-2025
- FDA classification
- Class II
- Brand / firm
- Howmedica Osteonics Corp.
- Sold / distributed
- Worldwide distribution - US Nationwide and the countries of Australia, Germany.
Why it was recalled
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
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