FDA Recall Open, Classified

Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)

Recall: Z-0654-2021 · Initiated October 7, 2019

Recall

Recall Number
Z-0654-2021
Event Number
86941
Firm
Nova Ortho-Med Inc
FEI Number
3002329391
Product Code
ITJ
Status
Open, Classified
Root Cause
Device Design
Initiated
October 7, 2019
Address
1470 Beachey Pl, Carson, CA, 90746-4002

Description

Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)

Reason

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.

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 ([email protected]) so that we can have for our records. If you prefer to call, then dial 1-800-557-6682 x8129. Email: [email protected]

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

Quantity

10898