Medical device recalls Moderate risk

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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