Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0044-2025 — MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

U.S. FDA — Device Enforcement · United States · 2024-08-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0044-2025
Date of alert
2024-08-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00848486030193
Reported risk: Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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