FDA-Device2022-10-05Class II
OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
Ossur Americas
Hazard
Battery may dislodge from the Power Knee
Sold states
U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, VA, VT, WA and WI.
Affected count
190 devices
Manufactured in
27051 Towne Centre Dr, N/A, Foothill Ranch, CA, United States
Products
OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1821-2022Don't want to check this manually?
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