Z-0304-2017Class II

4205 Journey Rolling Walker

Name: Z-0304-2017 4205 Journey Rolling Walker
Creator: Nova Ortho-Med Inc
Published: 2016-10-01
License: https://open.fda.gov/license/

Nova Ortho-Med Inc / initiated 2016-10-01 / Terminated / root cause: design

FDA source

Nova Ortho-Med Inc began a recall of 4205 Journey Rolling Walker Product Usage: used to assist people in walking on 2016-10-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0304-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-01
Posted: 2016-10-24
Terminated: 2017-02-06
Recalling firm: Nova Ortho-Med Inc
Product: 4205 Journey Rolling Walker Product Usage: used to assist people in walking
Product code: ITJ Walker, Mechanical
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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 ([email protected]). Customers can also 1-800-557-6682 x131.
Quantity in commerce: 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
Product codes and lots: Serial No. YA 4205RDFG004 TO YA4205RDFG0098 YZ4205BKFC0002 TO YZ4205RDFE0100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0304-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0304-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-24

Product code ITJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)