Recall Z-0788-2024— Ossur H / F
Class II · Ongoing
Class II FDA medical device recall by Ossur H / F, initiated 2023-12-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002. Reason: 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..
- Recalling firm
- Ossur H / F
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-26
- Firm location
- Reykjavik, N/A, Iceland
Product description
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.