FDA recall Z-0654-2021

Nova Ortho-Med Inc · Class II · device

Product

Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)

Reason for recall

Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.

Distribution

U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, WY O.U.S.: Taiwan

Key facts

Status
Ongoing
Initiation date
2019-10-07
Report date
2020-12-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Carson, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0654-2021