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-1821-2022

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief