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FDA Sends Stryker Warning Letter about Negligent Business Practices

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FDA Sends Stryker Warning Letter about Negligent Business PracticesAccording to a Reuters report published on March 12, the U.S. Food and Drug Administration (FDA) has sent Stryker a warning letter about its business practices and its marketing strategy. The letter follows a visit by the FDA to a Styrker plant in November 2012.

The FDA visited a Stryker plant in Portage, Michigan to conduct an inspection, and discovered that Stryker, the manufacturer of orthopedic implants, had been marketing implants without FDA approval. Furthermore, Stryker had also recalled one of their products without communicating this action to the FDA.

It appears that Stryker had been marketing the Neptune Waste Management System without having received approval from the FDA.

In June 2012, Stryker issued a voluntary recall of two of their hip implant devices. The recall included the Stryker Rejuvenate and the Stryker ABG II modular-neck hip stems. According to the Stryker website, the medical device manufacturer recalled the hip stems due to reports of corrosion.

The Stryker Rejuvenate and the Stryker ABG II modular-neck hip stems are metal-on-metal hip implants, which have recently come under heightened investigation by the FDA due to an increasing number of adverse event reports.

Patients who have received implants of the Stryker hip stems have experienced adverse local tissue reactions (ALTR) that can result in tissue inflammation and pain in the hip implant area. Caused by the release of metal ions from a metal-on-metal hip implant, ALTR has also been linked to metallosis, bone deterioration, and tissue and muscle death.

To lawyers at Carey Danis & Lowe, the FDA’s inspection of the Stryker Michigan plant is a significant piece of upholding consumer safety. Defective medical device lawyers at Carey Danis & Lowe strongly believe in holding medical device manufactuers accountable for their negligent business practices, especially in cases where they market products that have not been FDA approved.

For more information about recalled Stryker products, contact Carey Danis & Lowe. If you have received a defective and recalled Stryker hip implant, contact a lawyer at Carey Danis & Lowe to discuss your case. Call Carey Danis & Lowe at 800.721.2519 or submit a legal claim form.