Recall Z-0130-2025 ยท ITJ Walker, Mechanical
Nova Ortho-Med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
| Date | Oct 17, 2024 (initiated Aug 26, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On 09/25/2024, the firm sent via email an "Urgent: Medical Device Correction" letter to inform customers that 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 resulting in potential fall risks. Customers are instructed to: Immediately take the following steps to correct the affected units. 1. Print the NOVA MONARCH Model 4329 Product Recall Notice and post it in your store in a visible location to customers. 2. Check your |
| Quantity | 977 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.