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FDA Issues Stryker Corp. Warning Letter Over Neptune Waste Management System Recall

March 12, 2013 – This week, Stryker Orthopaedics received a warning letter from the U.S. Food & Drug Administration (FDA) for failing to notify of a device recall and other quality system concerns. Specifically, the letter cites Stryker for failing to inform the FDA of a recall for the Neptune Waste Management System, and for marketing the device without 510(k) clearance. The Neptune was recalled in June 2012 after two patients were injured – one fatally – when using the devices.

Free Stryker Neptune Waste Management System Lawsuit Evaluation: If you or a loved one has been seriously injured by the Stryker Neptune Waste Management System, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Stryker Orthopaedics and we can help.

What’s the problem?

The FDA’s warning letter was sent to Stryker in response to a November 2012 inspection at the company’s instrument division in Portage, Mich. The letter states that the company has submitted plans to correct the problems at the plant, and is fully cooperating with the administration to address the issues in a timely and efficient manner. Stryker’s earning have fallen sharply in recent months after it was forced to reimburse consumers for two recalled products – the Rejuvenate and ABG II modular-neck hip stems.

In September 2012, Stryker announced that it was expanding its Neptune Waste Management System recall to include the Neptune 1 Silver, Neptune 2 Ultra and higher-powered Neptune 2 Ultra models, which were found to lack the proper FDA clearance. The recall was announced after two reports of severe injuries were linked to the devices, which are used to collect fluid waste during surgery. In one case, a patient died after their passive chest drainage tube was attached to the Neptune 2 System, a high-vacuum, high-flow device. The initial recall was announced to inform the public that Stryker Neptune devices should never be connected to passive drainage tubes, a warning that was not listed on the label.

The FDA does not consider Neptune Waste Management Systems “to be legally marketed devices because their safety and effectiveness have not yet been determined,” Stryker said in a statement. “As such, FDA advises that the devices not be used.”

Do I Have a Stryker Neptune Waste Management System Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Stryker Neptune Waste Management System lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Free Stryker Neptune Waste Management System Lawsuit Evaluation: If you or a loved one has been seriously injured by the Stryker Neptune Waste Management System, you should contact our law firm immediately. You may be entitled to compensation by filing a Stryker Neptune Waste Management suit and we can help.

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