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.
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
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.
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.
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.
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.
Verify if your Mako Integrated Cutting System Handpiece has Catalog Number 209063 and one of the listed serial numbers from the recall.
The recall states that there is an issue with the characterization process that impacted the constant values assigned to the MICS Handpieces.
Check if your Mako Integrated Cutting System Handpiece has Catalog Number 209063 and one of the serial numbers listed in the recall notice.
The recall does not specify a remedy, so affected users should contact Howmedica Osteonics directly for further instructions.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0044-2025 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0044-2025 from Howmedica Osteonics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
