Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 — recall Z-0788-2024
U.S. FDA — Device Enforcement · Iceland · 2023-12-26 · Class II
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Reported risk: 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.
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