Assembly, Knee/shank/ankle/foot, External

RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.

OSSUR Power Knee REF PKA10003

Battery may dislodge from the Power Knee

Otto Bock Healthcare Products GmbH Genium X3

Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.

The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously a

The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.

RUSH81 Prosthetic Foot

Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure.

BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system:

Battery may over-heat during charging and smoke