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U.S. Department of Health and Human Services

Class 2 Device Recall Journey Rolling Walker

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  Class 2 Device Recall Journey Rolling Walker see related information
Date Initiated by Firm October 01, 2016
Date Posted October 24, 2016
Recall Status1 Terminated 3 on February 06, 2017
Recall Number Z-0304-2017
Recall Event ID 75408
Product Classification Walker, mechanical - Product Code ITJ
Product 4205 Journey Rolling Walker

Product Usage: used to assist people in walking

Code Information Serial No. YA 4205RDFG004 TO YA4205RDFG0098 YZ4205BKFC0002 TO YZ4205RDFE0100 
Recalling Firm/
Manufacturer		 Nova Ortho-Med Inc
1470 Beachey Pl
Carson CA 90746-4002
For Additional Information Contact
310-352-3600
Manufacturer 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 2		 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 (patricias@novajoy.com). 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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