Stryker Orthopaedics has recalled several versions of application software used with the Mako 3.0 and Mako 3.1 robotic-arm assisted surgery systems, affecting approximately 2,097 units worldwide. The recall was initiated because the system can experience a 'Software Error #3' (SE3) if it is not restarted or shut down before switching between different surgical applications, such as moving from a total knee replacement to a total hip replacement procedure. This software defect can lead to unexpected delays in medical treatment during surgery. Consumers should contact their healthcare provider or Stryker directly to ensure the software has been updated or to receive specific operating instructions to avoid this error.
The software error causes the robotic system to malfunction or stop working when switching procedure types without a full restart. This results in a delay in surgical treatment while the system is troubleshoot or rebooted, which can extend the time a patient is under anesthesia or prolong the operative procedure.
Procedural mitigation (Restart/Shutdown)
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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