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Bio Leg™
BIONICM INC. · Model BLP001T · UDI-DI 00860010894859
ISW
Prescription
1
510(k) clearances
85
Adverse events
10
Recalls
10
Facilities
Description
Large, black robotic prosthetic leg including knee joint, power cord, AC adapter, lower cover, instruction manual and other printed materials, for Trial
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-25 | Ossur H / F | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. |
| 2024-03-25 | Ossur H / F | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. |
| 2024-03-25 | Ossur H / F | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. |
| 2024-03-25 | Ossur H / F | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. |
| 2023-12-26 | Ossur H / F | 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 t |
| 2022-08-29 | Ossur Americas | Battery may dislodge from the Power Knee |
| 2015-08-12 | Otto Bock Healthcare Product | 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 |
| 2015-02-26 | Ossur H / F | 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 |
| 2014-06-02 | Ability Dynamics LLC | 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. |
| 2012-10-26 | iwalk inc | Battery may over-heat during charging and smoke |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.