FDA recall Z-0788-2024

Ossur H / F · Class II · device

Product

Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

Reason for recall

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2023-12-26
Report date
2024-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reykjavik, N/A, Iceland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0788-2024