Stryker Receives Warning Letter from FDA over Neptune Recall and Quality Concerns

Stryker device lawyers at Pintas & Mullins Law Firm report that the company recently received an FDA warning letter for failing to notify the agency of an extensive product recall and for other quality concerns.

In November 2012, the FDA inspected Stryker’s instruments division in Portage, Michigan. In the warning letter, the agency cites numerous observations made from that inspection concerning quality system failures. Earlier in 2012, Stryker initiated a Class I recall of its Neptune Rover Waste Management Systems, meaning the devices could cause serious injury or death in patients.

The Neptune products are intended to amass and dispose of surgical waste in operating rooms and facilities. One device, the Neptune 2 Ultra, eliminates the smoke generated by electro or laser devices used in surgical sites. All Neptune systems were recalled after two reports of serious tissue damage injuries were received. In one fatal event, a doctor was attempting to connect a Neptune 2 to a chest drainage tube after a surgery. The patient died, although there was no warning on the devices stating that connecting the system to a passive chest drainage tube was dangerous.

Stryker initially failed to notify the FDA about this Neptune recall. The company is also under fire by the FDA for marketing its Neptune Silver and Neptune 2 devices as safe and effective, although they do not currently have a 510 (k) clearance, which is required. A 510 (k) clearance requires device manufacturers to register with the FDA within 90 days before starting to market a device. This is also known as a premarket notification, or PMN. Advanced notification allows the FDA to fully evaluate whether the device being marketed is safe and effective. Stryker has reportedly submitted corrective action plans to the FDA about how they will resolve the quality system observations and recall issues.

This is not the first time Stryker has attempted to side-step federal regulations. In 2012 Stryker was ordered to pay the U.S. Department of Justice $33 million for marketing a knee device that was not cleared by the FDA. In 2007, the company paid the government $16 million over allegations of fraudulent health care billing. That same year, the FDA inspected Stryker plants in Cork, which led to all devices manufactured at that plant to be permanently taken off the market. The company spent $50 million bringing its facilities up to federal standards.

One month before the Neptune recalls, Stryker initiated a recall of two of its artificial hip implant systems: the Rejuvenate Modular and the ABGII Modular-Neck Hip Stems. Three months prior, the company sent an Urgent Field Safety Notice to surgeons and hospitals notifying them of the potential health risks associated with these devices. The hip implants show an increased risk of corrosion.

The products are manufactured with a titanium alloy blend that includes titanium, iron, zirconium, and molybdenum. When the devices corrode, small particles of metal can flake off and release into the body and cause severe metallosis, or metal toxicity. This type of toxicity can cause serious injuries around the implant site, including bone loss, tissue death, and potential damage to the kidney, liver, and other internal organs.

Many patients were forced to undergo painful and expensive corrective surgeries from the defective Rejuvenate and ABGII products. Patients may experience symptoms such as pain and swelling around the hip, squeaky joints, muscle loss, fluid collection, and bone fractures.

Victims of defective Stryker devices may be entitled to compensation through a product recall lawsuit. Claims of this type continue to mount, and many have already resulted in millions of dollars in settlements. Stryker product lawyers at Pintas & Mullins Law Firm are currently accepting claims involving any defective Stryker products, including the Rejuvenate, ABG II, Trident, and Neptune devices.