Class 2 Device Recall Fuze Manual Tilt Wheelchair

• Date Initiated by Firm: June 12, 2012
• Date Posted: September 24, 2014
• Recall Status: Terminated on July 23, 2015
• Recall Number: Z-2695-2014
• Recall Event ID: 69035
• 510(K)Number: K063736
• Product Classification: Wheelchair, mechanical - Product Code IOR
• Product: Fuze Manual Tilt Wheelchair. ; Fuze T50, Fuze T20 and Fuze T50 Jr
• Code Information: Fuze T50, Fuze T20 and Fuze T50 Jr 52752 52794 52750 52667 52679 52692 52729 52745 52779 52826 52865 52878 52823 52912 52804 52666 52680 52702 52731 52746 52780 52827 52866 52879 52749 52913 52753 52669 52682 52703 52732 52747 52781 52828 52867 52880 52696 52796 52734 52670 52681 52695 52735 52768 52782 52856 52868 52881 52748 52705 52701 52671 52683 52707 52736 52770 52802 52857 52869 52882 52825 52699 52698 52672 52684 52708 52737 52771 52803 52858 52870 52883 52829 52706 52834 52668 52685 52710 52738 52772 52805 52859 52871 52884 52916 52751 52821 52673 52687 52709 52739 52773 52806 52860 52872 52885 52767 52799 53192 52674 52690 52711 52740 52774 52807 52861 52873 52886 52795 52914 52663 52676 52688 52726 52741 52775 52808 52862 52874 52887 52919 52824 52664 52677 52691 52728 52742 52776 52809 52863 52876 52888 52831 52918 52665 52675 52693 52727 52743 52777 52810 52864 52877 52889 52754 52917 52733 52678 52694 52730 52744 52778 52811
• Recalling Firm/ Manufacturer: Pdg Product Design Group Inc; 9165 Shaughnessy St; Vancouver Canada British Columbia
• Manufacturer Reason for Recall: The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use.
• FDA Determined Cause: Component design/selection
• Action: PDG Product Design group sent all Canadian customers via an e-mail dated August 9, 2012. The letter identified the product the problem and the action needed to be taken by the customer. Immediately call PDG Customer Service @ 1-888-858-4422. Advise the Customer Service Representative that you have received this letter. Our Customer Service Representative will be happy to organize for you to receive a brand new chair. In the United States, we initially notified our Comfort Company who is our only United States Sales Representative. Comfort Company then notified U.S. Consignees via a letter which is provided for your reference. Also a letter was sent to our biggest customer in the USA, which is Cair Medical. It was sent on December 12, 2012 (PDG Letter to Cair Medical Fuze recall) to explain and outline how PDG handled the Fuze hex bolts breaking. A copy of this letter is also provided for your reference. Our Hong Kong customers were informed thru e-mail. Non- respondents were re- contacted by either e-mail or telephone. Effectiveness checks were done thru telephone. Defective product on hand at our facility has been scrapped and destroyed. Defective product that was removed from wheelchairs in the field was destroyed at the time the bolts were replaced.
• Quantity in Commerce: 153
• Distribution: Worldwide Distribution- US Distribution including the states of : AZ, CA, GA, KY, MI, MN, MO, MS, NC, NE, NY, OH, PA, SC, TX, VA, and WA., and Internationally to Canada and Hong Kong.
• 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.

• 510(K) Database: 510(K)s with Product Code = IOR and Original Applicant = PDG PRODUCT DESIGN GROUP, INC.