MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Reported: October 16, 2024 Initiated: August 7, 2024 #Z-0044-2025
Product Description
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.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 897 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Germany.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063. Recalled by Howmedica Osteonics Corp.. Units affected: 897 units.
Why was this product recalled? ▼
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0044-2025.
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