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OtisMed worked with Stryker in developing unapproved knee device

March 27th, 2015

OtisMed reportedly worked closely with Stryker Corporation while developing its OtisKnee surgical guide, a device which was unapproved but still used in surgery. The company reportedly sold $27 million worth of the OtisKnee, a surgery cutting guide, before the U.S Food and Drug Administration rejected the device for safety concerns.

According to the New York Times, Stryker Corporation made knee replacement components that worked with the OtisKnee devices prior to acquiring OtisMed in 2009. Dozens of patients have since come forward with complaints of severe complications from surgeries involving the OtisMed devices. A Stryker employee filed a whistle-blower lawsuit against the companies in 2009.

Stryker has a history of surgical devices that could cause serious injuries, as evidence by its recalled Strkyer Rejuvenate and Stryker ABG II metal-on-metal hip replacements. The company recently reached a $1.4 billion agreement to settle Stryker lawsuits alleging that the metal hip replacements failed and caused serious injuries, such as tissue damage and toxic levels of metal in the blood stream.

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