ClearanceBrief
Recall Z-0304-2017 ยท ITJ Walker, Mechanical

Nova Ortho-Med Inc

4205 Journey Rolling Walker Product Usage: used to assist people in walking

DateOct 24, 2016 (initiated Oct 1, 2016)
StatusTerminated
ReasonNova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out.
Root causeComponent design/selection
ActionA customer notification letter dated 10/1/16 was sent to customers to inform them that the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out. This allows the frame support piece to detach from the walker and causes instability resulting in possible injury. The letter informs the customers of the root cause and the solution. Customers are instructed to record the serial #s of the product that have been corrected and email them to NOVA Customer Service (patricias@novajoy.com). Cust
Quantity1,380 units
DistributionUS Nationwide Distribution in the states of: CA, IN, HI, CT, UT, WA, FL, VA, WI, OH, MN, KS, MD, IL, MO, WY, MT, ME, PA, TN, MI, OR, NY, NJ, ID, NC, IA, OK, AR, VT, SC, TX
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.