Ossur Americas recalls OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA0100…

Recall date

August 29, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1821-2022

FDA classification

Class II

Brand / firm

Ossur Americas

Sold / distributed

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.

Why it was recalled

Battery may dislodge from the Power Knee

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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