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FDA submits warning letter to Stryker over quality concerns

March 15th, 2013

The Food and Drug Administration (FDA) has sent a warning letter to Stryker Corporation related to quality concerns at one of its facilities. The agency’s letter also warned the orthopedic implant company that it had been marketing devices without approval and failed to notify the FDA of a product recall.

Stryker is currently facing hip replacement lawsuits alleging that its Rejuvenate hip replacements and ABGII hip replacements fail at a high rate, often requiring revision surgery. Stryker issued a hip implant recall in July 2012 after thousands of complaints from patients.

The Stryker Rejuvenate and Stryker ABGII hip systems have been found to corrode and fret after being installed in patients. The defective devices could lead to severe complications, including limited mobility, tissue damage and revision surgery to remove the device.

 

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