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Recall Observatory FDA recall evidence

Device product

Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID

Z-0131-2025

August 26, 2024

Class II

Product summary

Firm
Nova Ortho-Med Inc
Event
Event 95375
Status
Ongoing
Classification
Class II
Quantity
1585
Official record key
device-enforcement:Z-0131-2025

Official wording

Reason: Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.

Code information: Lot Code: ITEM CODE: 4329RD SN RANGE: HT4329RDME0001 - HT4329RDMM0420 UPC: 652308012263

Distribution pattern: Worldwide - U.S. Nationwide distribution including in the states of AK, AL AZ, CA, CO, CT, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI and WY. The country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.