Howmedica Osteonics recalls Mako Integrated Cutting System Handpiece with characterization
Howmedica Osteonics recalls Mako Integrated Cutting System Handpieces (Catalog 209063) due to potential characterization process errors affecting constant values. Affected units have specific serial numbers listed in the recall.
Recall notice
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Contact the company
What happened, in plain English
Howmedica Osteonics is recalling certain Mako Integrated Cutting System Handpieces (Catalog Number 209063) because of an issue with the characterization process that impacts the constant values assigned to these devices. This could affect how the handpieces function during surgical procedures. Read more at govinfonow.com/recall/54276-howmedica-osteonics-recalls-mako-integrated-cutting-system-handpiece-with-characterization.
Source Summary by GovInfoNow · govinfonow.com/recall/54276-howmedica-osteonics-recalls-mako-integrated-cutting-system-handpiece-with-characterization · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0044-2025
Cite this page
“Howmedica Osteonics recalls Mako Integrated Cutting System Handpiece with characterization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54276-howmedica-osteonics-recalls-mako-integrated-cutting-system-handpiece-with-characterization. Based on FDA recall #Z-0044-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0044-2025%22&limit=1).
Why it’s dangerous
The recall states that there is an issue with the characterization process that impacted the constant values assigned to the MICS Handpieces. This could lead to improper functioning of the handpieces during surgical procedures, potentially affecting the accuracy or safety of the surgery.
Who’s affected
Surgical professionals who own or use the recalled Mako Integrated Cutting System Handpieces (Catalog Number 209063) with specific serial numbers listed in the recall. Patients using these devices during surgery may be at risk if the handpieces malfunction.
How to tell if you have this one
Check if your Mako Integrated Cutting System Handpiece has Catalog Number 209063 and one of the listed serial numbers (4200075, 4200134, 4200177, etc.). The full list of affected serial numbers is provided in the recall notice.
- Brand
Howmedica Osteonics- Product
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063- Category
Medical device
What to do — step by step
Check Product Serial Number
Verify if your Mako Integrated Cutting System Handpiece has Catalog Number 209063 and one of the listed serial numbers from the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0044-2025 (August 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0044-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.