Home › Device types › ISW
Assembly, Knee/Shank/Ankle/Foot, External
FDA product code ISW · Class 2 · Physical Medicine
786
Registered devices
85
Adverse events
10
Recalls
1
510(k) clearances
Devices with this code
Empower — OTTO BOCK HEALTHCARESymbionic Leg — OSSUR AMERICAS, INC.Empower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREPower Knee — OSSUR AMERICAS, INC.Empower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCARESymbionic Leg — OSSUR AMERICAS, INC.Empower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREPower Knee — OSSUR AMERICAS, INC.Empower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCAREEmpower — OTTO BOCK HEALTHCARE
Recent 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 momen |
| 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 f |
| 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 distrib |
| 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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