Recall Z-1821-2022— Ossur Americas

Class II · Ongoing

Class II FDA medical device recall by Ossur Americas, initiated 2022-08-29. FDA's recall record names no specific 510(k) clearance for this event. Product: OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T. Reason: Battery may dislodge from the Power Knee.

Recalling firm
Ossur Americas
Classification
Class II
Status
Ongoing
Initiated
2022-08-29
Firm location
Foothill Ranch, CA, United States

Product description

OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T

Reason for recall

Battery may dislodge from the Power Knee

Data sourced from openFDA. This site is unofficial and independent of the FDA.