Medical Device Recall: Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Ossur H / F · December 26, 2023
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.
Distribution
US Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA, IL, NJ, FL, MI, NY, AL, TX, OK, IN, GA, CA, PA, NM, VT, NV, MS, HI, OH, WI, LA, IA, NE, MN, AR, OR, NC, NH, WV, CO, ID, AZ, MO, CT, WA, KY, UT, KS.
States Affected
NATIONWIDE
Quantity Affected
544 Batteries
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0788-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.