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Attune Knee Replacement System

Recall Information
Recalled in June 2015 for early failure and destabilization of the knee.

News & Alerts on the Medical Device Industry

ATTUNE® Knee Replacement System
In June of 2015 the FDA recalled the ATTUNE® Knee Replacement System which is made and marketed by DePuy Synthes, a medical device division of Johnson & Johnson. In its warning letter to DuPuy, the FDA stated that parts of the knee replacement system were changed or replaced without FDA approval and that these parts were dangerous and could result in painful, costly and time consuming revision surgery. Worldwide, more than 700,000 total knee replacement surgeries used the Attune device.
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May 7, 2019

Johnson & Johnson agrees to pay $1 Billion for defective metal-on-metal Pinnacle hip replacements made by DePuy, its medical device subsidiary.

April 17, 2019
U.S. Food & Drug Administration

FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion

March 26, 2019
Fox News

FDA Chief Gottlieb to Resign

March 15, 2019
Fierce Biotech

The FDA acknowledged that there is growing evidence that some patients may be predisposed to pain caused by certain materials used in medical devices such as hip and knee implants.


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Medical Device Watch is sponsored by Keefe Law Firm. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.


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