Recall Z-0654-2021— Nova Ortho-Med Inc
Class II · Ongoing
Class II FDA medical device recall by Nova Ortho-Med Inc, initiated 2019-10-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Nova Ortho-Med Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-10-07
- Firm location
- Carson, CA, United States
Product description
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.