Stryker Recalls Neptune Devices in Wake of Hip Implant Recall
Just months after Stryker Orthopedics issued a voluntary product recall of its ABG II modular-neck stem, the United States Food and Drug Administration (U.S. FDA) released reports of Stryker issuing a Class 1 recall of its Neptune Rover Waste Management System in the United States as well as parts of Asia and Latin America. This Class 1 recall is the most serious level of a device recall and did so following two people had reported serious injury, one fatally, from using the Neptune Waste Management System.
In June 2012, Stryker initiated a Class 1 to warn consumers that the devices should not be connected to any passive drainage tubes, which was not included in the warning label on the product. However, in September 2012, the company extended the recall to inform customers that the Neptune 1 Silver, Neptune 2 Ultra and a higher-powered Neptune 2 Ultra did not have the approval of the U.S. Food and Drug Administration.
According to a statement released by Stryker, “[The FDA doesn’t consider the devices] to be legally marketed devices because their safety and effectiveness have not yet been determined…As such, FDA advises that the devices not be used.”
This news, as mentioned, comes just a few months following Stryker’s recall of its hip implant systems, Rejuvenate and ABG II Modular Neck-System. Both systems contained various sizes of neck and stem components, allowing doctors and surgeons to create a custom fit when building a patient a new hip for hip replacement surgery. The components, however, are made of metal and lead to the same dangerous effects to be found of other metal-on-metal hip implant components, such as the Zimmer “Durom Cup” and DePuy ASR hip replacement system. When the metal neck and metal stem rubbed together, it can cause the device to weaken and even fail within a few years of the hip replacement surgery. Additionally, the grinding metal can leave a significant amount of metal resiudue, causing cases of metallosis (also known as metal poisoning).
An estimated 20,000 Stryker Rejuvenate or ABG II hip components were sold in the United States before the recall in July 2012. Patients who have received or think they may have received one of these faulty implants are encouraged to contact a qualified attorney who can properly advise them of what actions to take.
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