Recall Z-0304-2017
Nova Ortho-Med Inc · initiated October 1, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
4205 Journey Rolling Walker Product Usage: used to assist people in walking
Codes / lots: Serial No. YA 4205RDFG004 TO YA4205RDFG0098 YZ4205BKFC0002 TO YZ4205RDFE0100
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.
FDA-determined cause: Component design/selection
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.
Details
- Recall number
- Z-0304-2017
- Initiated
- October 1, 2016
- Posted by FDA
- October 24, 2016
- Terminated
- February 6, 2017
- Product code
- ITJ – Walker, Mechanical
- Quantity
- 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
- Recalling firm
- Nova Ortho-Med Inc, Carson, CA