Tuesday, October 9, 2012

Stryker Expands Recall of Waste Systems Just Months After Hip Recall

[This story sounds familiar!!]

October 8, 2012 by: Linda Grayling   for Drug Watch     
Medical device manufacturer Stryker Corp. is dealing with yet another recall — this time, it’s the Neptune waste-management products.

The company first voluntarily recalled the Neptune 1 in June after two people were seriously injured and another died when the first-generation device was used during their surgeries. The suction system is designed to collect surgical fluid waste and smoke from electrocautery or laser devices, Reuters states.

Stryker officials said the Class 1 recall — the most serious for a medical device manufacturer — was issued because the device’s label did not warn health care providers that the Neptune should not be connected to passive drainage tubes, Bloomberg Businessweek reports. When this happened in the three reported cases, patients suffered hemorrhaging and soft tissue, muscle and organ damage.

Recall Expanded After FDA Warning

On Sept. 18, Stryker expanded the recall to include later versions of the Neptune because of a U.S. Food and Drug Administration (FDA) notification. According to a company statement, the FDA said that the devices are not considered “legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used.”

The Neptune 1 Silver and the Neptune 2 Ultra were not formally approved by the FDA. Instead, Stryker claimed they were “substantially equivalent” to other devices that had received prior approval. Although this practice is allowed, it has raised many concerns in recent years because of the number of complications, injuries and deaths that could have been avoided if various devices had been subject to rigorous clinical trials.

Stryker has advised patients who cannot use alternative surgical devices to request a certificate of medical necessity if they must continue use of a Neptune system.

Stryker Recalls Hip Replacement Components

At the same time Stryker is contending with the Neptune system recalls, the orthopedic implant manufacturer also is facing a growing number of lawsuits stemming from another recall of defective devices. In July, Stryker recalled its popular components used in hip replacement surgeries — the Rejuvenate and ABG II modular-neck hip stems.

Both systems contain necks and stems of various sizes, allowing a surgeon to create a custom fit when building a new hip. Unfortunately, the components are made of metal, leading to the same dangerous effects of other metal-on-metal hip implants. When the metal neck and metal stem rub together, it can cause the device to weaken and fail within a couple years of implantation. In addition, the grinding can produce metal shavings, which have been linked to metallosis, or metal poisoning.
It is estimated that about 20,000 people in the United States were implanted with Stryker Rejuvenate or ABG II hip components.

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