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FDA releases info on medical device tracking system

August 27th, 2014

The U.S. Food and Drug Administration has created the unique devices identification system (UDI) in order to track and monitor outcomes of medical devices, including defective hip replacements. The system states that manufacturers such as Stryker must include product identification and tracking information that will tell doctors if certain devices have been recalled or been discontinued. All devices must be compliant by 2016.

Medical device companies such as Stryker Orthopedics have come under fire for releasing defective products, many of which are implanted in unknowing patients. Stryker issued a hip replacement recall for its Rejuvenate and ABG II metal-on-metal hip implants in 2012 after patients complained of severe side effects.

Stryker hip replacement side effects include premature loosening of the hip joint, tissue damage, pain, limited mobility and toxic levels of metal in the bloodstream. Hundreds of patients have filed Stryker lawsuits alleging that the company released a defective device that required revision surgery to correct complications.

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