FDA recall Z-0044-2025

Howmedica Osteonics Corp. · Class II · device

Product

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

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.

Key facts

Status
Ongoing
Initiation date
2024-08-07
Report date
2024-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0044-2025