Class II

Medical Device Recall: MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

Howmedica Osteonics Corp. · August 7, 2024

Reason for Recall

Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Germany.

States Affected

NATIONWIDE

Quantity Affected

897 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0044-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Howmedica Osteonics Corp. Medical Device Recall: MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 | SafeCheck