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Ossur H / F recalls Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Recalled January 31, 2024 · FDA recall Z-0788-2024 · Ossur H / F
Hazard
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. · FDA Class II
Units
544 Batteries
Sold at
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.
Description
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.
Product
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Manufacturer(s)
Ossur H / F
Made in
Iceland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →