Class 2 Device Recall NOVA ORTHOMED INC.

• Date Initiated by Firm: August 26, 2024
• Date Posted: October 17, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0131-2025
• Recall Event ID: 95375
• Product Classification: Walker, mechanical - Product Code ITJ
• Product: Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
• Code Information: Lot Code: ITEM CODE: 4329RD SN RANGE: HT4329RDME0001 - HT4329RDMM0420 UPC: 652308012263
• Recalling Firm/ Manufacturer: Nova Ortho-Med Inc; 1470 Beachey Pl; Carson CA 90746-4002
• For Additional Information Contact: KYLE ISHIDA; 310-352-3600
• Manufacturer 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.
• FDA Determined 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 inventory for 4329 model walkers (4329BL, 4329PL and 4329RD), isolate and hold the products until you contact NOVA ORTHO-MED INC for the next steps. 3. Contact all customers who purchased a 4329 model to notify them of the potential issue. Schedule a time that they can come in for repair or if the customer prefers NOVA can send the replacement components directly to their residence. 4. If you do not track serial numbers with customer purchase or do not have the customer information, please ensure that the NOVA MONARCH Model 4329 Product Recall Notice document is posted in a customer visible location. 5. Call NOVA customer service and request the replacement component to be sent to the required location. (Part# - HCT-432915) 6. Record the serial # s of the product that have been corrected and email them to NOVA Customer Service (info@novajoy.com) so that we can have for our records. If you prefer to call, then dial 1-800-557-6682. For questions or assistance - Contact Information: Monday through Friday, 8:30 AM to 5:00 PM, Pacific time Time. "Toll free number: 1-800-557-6682 "Email: info@novajoy.com
• Quantity in Commerce: 1585
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.