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Recall Observatory FDA recall evidence

Device product

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

Z-0654-2021

October 07, 2019

Class II

Product summary

Firm
Nova Ortho-Med Inc
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

    reason.no_named_rule · v1.0.0

    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.