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U.S. Department of Health and Human Services

Class 2 Device Recall Star 8 Rolling Walker/Rollator

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  Class 2 Device Recall Star 8 Rolling Walker/Rollator see related information
Date Initiated by Firm October 07, 2019
Create Date December 21, 2020
Recall Status1 Open3, 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 2		 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.
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