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Power Knee PKA10001Recalls & reported problems

Ossur Americas, Inc. · Power Knee incl 2Y warranty · Class 1

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Dec 26, 2023Open, Classified

    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.

    Z-0788-2024 · Root cause: Process control · FDA record ↗

  2. Aug 29, 2022Open, Classified

    Battery may dislodge from the Power Knee

    Z-1821-2022 · Root cause: Device Design · FDA record ↗

Other Joint, Knee, External Limb Component devices

All Joint, Knee, External Limb Component devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.