FDA (Devices) recall action 94332
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ossur is recalling 107 RHEO Knee XC prosthetic components due to firmware issues that may cause unintended device shutdown or warnings, risking patient falls.
Ossur H/F is recalling RHEO KNEE prosthetic knee components due to firmware issues that could cause unintended warnings and device shutdown, creating fall risk for users.
The RKNXC0005 RHEO KNEE XC prosthetic knee may experience firmware issues causing unintended warnings and device shutdown, creating a fall risk for patients.
Ossur RHEO KNEE prosthetic units recalled due to firmware issues causing unintended warnings and device shutdown, which could result in patient falls.