Device product
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Z-0654-2021
Product summary
- Event
- Event 86941
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10898
- Official record key
device-enforcement:Z-0654-2021
Official wording
Reason: 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.
Code information: Serial # range: HF-4258BKHA0001 to HF4258RDHK0352 (Purchased before April 4th,2019)
Distribution pattern: 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
Derived failure modes
-
Unknown
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.