Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
FDA device recall Z-2695-2014 · posted 2014-09-24 · Terminated
Recall details
- Recalling firm
- Pdg Product Design Group Inc
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 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.
- Date initiated
- 2012-06-12
- Date posted
- 2014-09-24
- Date terminated
- 2015-07-23
- Location
- Vancouver, British Columbia, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 (K063736) | Pdg Product Design Group, Inc. | 2007-01-17 |