Class 2 Device Recall Star 8 Rolling Walker/Rollator

• Date Initiated by Firm: October 07, 2019
• Create Date: December 21, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0654-2021
• Recall Event ID: 86941
• Product Classification: Walker, mechanical - Product Code ITJ
• Product: Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
• Code Information: Serial # range: HF-4258BKHA0001 to HF4258RDHK0352 (Purchased before April 4th,2019)
• Recalling Firm/ Manufacturer: Nova Ortho-Med Inc; 1470 Beachey Pl; Carson CA 90746-4002
• For Additional Information Contact: Annette Aoyoma; 310-352-3600 Ext. 8106
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: On 10/07/2019, Product Correction and Product Safety Recall notices were emailed to customers. Customers were asked to replace the front leg assemblies as follows: a. Depress the push buttons on the original legs and remove them from the frame. b. Insert the improved replacement assemblies issued by NOVA into the unit and discard the original legs. In addition, customers were asked to do the following: 1. Check your inventory for affected walkers and fix. 2. Contact all customers who purchased affected walkers notify them of the potential issue. Schedule a time that they can come in for repair or if the customer prefers the recalling firm can send the wheel assemblies directly to their residence. Have them inspect their walker immediately to identify if either of the front forks have unscrewed from the leg. If so, please instruct them to not use the walker until the leg assemblies can be replaced with the new parts. 3. Call the recalling firm to request the wheel assembly set to be sent to the required location. 4. Record the serial #'s of the product that have been corrected and email them to Customer Service (info@novajoy.com) so that we can have for our records. If you prefer to call, then dial 1-800-557-6682 x8129. Email: info@novajoy.com
• Quantity in Commerce: 10898
• Distribution: 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
• 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.