Howmedica Osteonics Corp. (Stryker) is recalling 897 units of the MAKO Integrated Cutting System (MICS) Handpiece due to an issue with the characterization process. This defect resulted in incorrect constant values being assigned to the handpieces, which are critical for the device's surgical performance. These surgical devices were distributed nationwide and internationally between various manufacturing dates, and the firm is initiating this voluntary recall through direct notification letters.
Incorrect constant values assigned to the handpiece can lead to inaccuracies during surgical cutting procedures. This could potentially result in unintended tissue damage or surgical complications if the robotic-assisted system does not perform according to the surgeon's expectations.
Manufacturer initiated recall notification and instruction
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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