The first issue was the use of the Corail Hip System that stated it was used for 2 non approved uses with marketing both on line and with brochures and I’m not quite sure what this is about but the FDA is questioning as I thought if you needed a hip you needed one and the surgeon and sometimes the patient helps make that decision. The FDA states that there are 2 conditions mentioned that should not be listed for use of the system.
The other issue has to do with the software used to position a knee which to me seems like a benefit but as the FDA states it needs to be approved. Many companies are using such software these days but the FDA states the TruMatch system needs approval. There are some of the DePuy products that are being phased out which came out earlier this year do to high failure rates.
Lawsuit Filed Against DePuy (Johnson & Johnson Subsidiary) Over Defective Hip That Had to Be Replaced
Johnson and Johnson though did buy another hip and knee device company a few months ago so perhaps this is where the answer lies with future devices. BD
Johnson and Johnson Company, DePuy Orthopedics Acquires Finsbury Orthopaedics from the UK
TRENTON, NJ. – A Johnson & Johnson business that makes joint replacements has been warned by the Food and Drug Administration that it is illegally marketing two products.
The FDA notified Johnson & Johnson's DePuy Orthopaedics Inc. that it is selling one product that was never approved for sale and is selling another product for uses that have not been specifically approved.
The agency also stated that it never approved the TruMatch Personalized Solution System. It uses software and high-tech CT scanning technology to create a detailed, 3-D view of a patient's knee so a surgeon can properly position a knee implant.
Johnson & Johnson gets FDA warning on marketing - Yahoo! News
0 comments :
Post a Comment