Read about Stryker's Response to the FDA from our Law Firm

From our Lawyers: The FDA has ordered Stryker Corp. to address a number of problems in its manufacturing of hip replacement parts that have resulted in multiple complaints and forced some to have second surgeries. Some of the problems have included incorrect fitting of hip implants that caused bone fractures. Patients also have complained about pain, difficulty walking and "squeaky" joints, and some have had pieces of implant parts break off.

"Your firm has failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems," the Nov. 28 letter states more than once.

FDA states in the letter that if Stryker does not correct the violations promptly, the FDA can act to seize property, levy fines and seek injunctions. The FDA will also not approve the sale of specific new Stryker medical devices until the violations are addressed and that it will notify federal agencies, so they can consider it when awarding contracts.

Stryker's response: "We take these matters very seriously and are committed to developing, manufacturing and marketing medical products that are safe and effective and that comply with applicable laws and regulations," it said. "We have been working diligently for the past several months to respond to the FDA and will continue to work closely with them to address these matters."

If you have questions regarding your Stryker implant, please contact us using the form below.

Patent Dispute

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Stryker's First Response to FDA Warning

Learn from our lawyers about the FDA letter to Stryker
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News & Warnings

Read the FDA Warning Letter re: Stryker Hip Implants.
FDA issues Warning Letter re: Stryker Hip Implants. Get the info here.

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