FDA-Device2024-10-16Class II
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Howmedica Osteonics Corp.
Hazard
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Germany.
Affected count
897 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0044-2025Don't want to check this manually?
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