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

FDA device recall Z-0304-2017 · posted 2016-10-24 · Terminated

Recall details

Recalling firm

Nova Ortho-Med Inc

Reason for recall

Nova 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.

Action taken

A 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). Customers can also 1-800-557-6682 x131.

Root cause

Component design/selection

Status

Terminated

Product code

ITJ

Quantity affected

1,380 units

Distribution

US 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

Date initiated

2016-10-01

Date posted

2016-10-24

Date terminated

2017-02-06

Location

Carson, CA