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FDA to DePuy- Stop Making Unapproved Implants

Yesenia Martinez5 years ago

The Food and Drug Administration (FDA) is warning Johnson & Johnson’s DePuy Orthopaedics to stop the production of non-FDA approved artificial knees and hip replacement implants.

FDA Warning Letter to DePuy

The FDA sent DePuy a warning letter on December 8, 2011 after investigators found the company producing devices without FDA approval. DePuy claims the devices do not need approval since they are custom-made for patients. The FDA responded that there were too many of the same item produced to be classified as custom and that although they had some size and shape differences, the design characteristics stayed consistent among the devices. The devices in question are:

  • PFC Sigma Knee System components
  • Agility Total Ankle Prosthesis talar components and “Augments”
  • Global Advantage Shoulder System components
  • TriFlange Acetabular Cups
  • Femoral heads
  • Hip arthroplasty system adapters

Consequences of Producing Unapproved Devices

The FDA warns that the manufacture of unapproved medical devices may lead to negative consequences including:

  • Poor design suitable validation procedures
  • Not having a process for handling customer complaints
  • Failure to detect quality problems
  • Other regulatory issues
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Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.


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