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DePuy recall prompts new legislation

Posted on January 12th, 2012 No Comments

The August 2010 recall of DePuy’s ASR hip implant recently prompted three members of the U.S. Senate to introduce legislation that would require medical device manufacturers to track their devices and take record of the patients who use them.

To complicate DePuy’s recall of thousands of ASR hip replacements all over the world, the company did not keep a list of the patients that their devices were implanted in.  As a result, DePuy was unable to personally contact its consumers and inform them of the recall and risks associated with the device.

The DePuy ASR XL Acetabular System and Hip Resurfacing Systems were approved under the FDA’s 501(k) provision.  This provision allows new devices that are similar to a product the FDA has already approved to be approved without testing on patients.  The proposed legislation would only apply to devices approved under the 501(k) provision and that have not undergone human testing.

Contact the DePuy hip recall lawyers of Williams Kherkher by calling 800-761-3187 today, if you or a loved one has experienced hip implant failure with a recalled DePuy ASR hip replacement.

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