Recall Z-0129-2025— Nova Ortho-Med Inc
Class II · Ongoing
Class II FDA medical device recall by Nova Ortho-Med Inc, initiated 2024-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID. 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..
- Recalling firm
- Nova Ortho-Med Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-26
- Firm location
- Carson, CA, United States
Product description
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.