FDA Medical Device Recalls (openFDA)
Nova Ortho-Med Inc: Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
- Recall number
- Z-0654-2021
- Recalling firm
- Nova Ortho-Med Inc
- Product
- Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
- Status
- Open, Classified
- Initiated
- 2019-10-07
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root 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
- 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
- Lot, serial or model codes
- Serial # range: HF-4258BKHA0001 to HF4258RDHK0352 (Purchased before April 4th,2019)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITJ
- Firm FEI
- 3002329391
- Firm city
- Carson
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28