FDA-Device2024-01-31Class II
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
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.
Sold states
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.
Affected count
544 Batteries
Manufactured in
Grjothals 5, N/A, Reykjavik, N/A, Iceland
Products
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0788-2024Don't want to check this manually?
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