Recall Z-0654-2021 ยท ITJ Walker, Mechanical
Nova Ortho-Med Inc
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
| Date | Oct 7, 2019 |
| Status | Open, Classified |
| 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 re |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.