Power Knee PKA10002Recalls & reported problems

Ossur Americas, Inc. · Power Knee Battery · Class 1

All models of Power Knee (5)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names 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: 1

Summary

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

1 FDA recall record name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

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 · Recall details · FDA record ↗

Device details

UDI-DI	`05690967648404`
Brand	Power Knee
Model	PKA10002
Company	Ossur Americas, Inc.
Product code	ISY · Joint, Knee, External Limb Component
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 1, 2025

Device type (GMDN): Motorized external knee prosthesis

An active-power electromechanical device, with rechargeable batteries, which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for motion control is based on a motorized mechanism which exerts significant forces on the user to actively propel the user, especially during stance phase, for support during a variety of activities.

Other Joint, Knee, External Limb Component devices

Power Knee PKA10003
Ossur Americas, Inc. · Joint, Knee, External Limb Component
2 recalls1 report
Power Knee PKA10001
Ossur Americas, Inc. · Joint, Knee, External Limb Component
2 recalls0 reports
Rheo Knee RKN130003
Ossur Americas, Inc. · Joint, Knee, External Limb Component
1 recall5 reports
Rheo Knee RKNXC0003
Ossur Americas, Inc. · Joint, Knee, External Limb Component
1 recall3 reports
Rheo Knee RKNXC0005
Ossur Americas, Inc. · Joint, Knee, External Limb Component
1 recall1 report
Rheo Knee RKN130002
Ossur Americas, Inc. · Joint, Knee, External Limb Component
1 recall0 reports
Power Knee PKA01001L
Ossur Americas, Inc. · Joint, Knee, External Limb Component
1 recall0 reports
Power Knee PKA01001T
Ossur Americas, Inc. · Joint, Knee, External Limb Component
1 recall0 reports

All Joint, Knee, External Limb Component devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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