FDA Warns Stryker Yet Again
The FDA has recently issued a warning letter to Stryker, as reported by the law firm of Pintas & Mullins. The FDA conducted an inspection of the instruments division at Stryker’s Portage, Michigan location this past November. During the inspection, the agency observed numerous failures within the quality system. The letter cited these concerns, as well as failing to inform the FDA of a substantial product recall.
In 2012, a recall at the Class I level was instated for Stryker’s Neptune Rover Waste Management Systems. The recall resulted from the product possibly causing considerable injury to patients, or death.
The Neptune systems were designed to collect and dispose of waste created during surgeries. Following receipt of two separate reports claiming serious injuries regarding damage to tissue, Stryker recalled all Neptune systems. One event proved fatal when a patient died after their doctor tried to connect a Neptune 2 to a drainage tube in their chest. The device was void of any warning regarding the danger of connecting the Neptune 2 to a tube used for chest drainage. Stryker did not immediately alert the FDA to the recall.
The FDA is also concerned with Stryker marketing their Neptune 2 and Neptune Silver devices, despite not having the required 510(k) clearance, or pre-market notification. This clearance ensures manufacturers register their devices 90 days prior to marketing, providing the FDA the opportunity to conduct a full evaluation and determine the device’s safety and effectiveness. Stryker has allegedly provided plans to perform corrective actions to the FDA, detailing how they intend to rectify the negative observations of the quality systems, and address the recall.
Stryker is not a first time offender when it comes to avoiding federal regulations. Last year they paid $33 million to the U.S. Department of Justice for not receiving FDA clearance before marketing knee devices. In 2007, they coughed up $16 million related to fraudulently billing health care agencies. Also in 2007, an FDA inspection of their plants located in Cork led to all devices at that plant being permanently pulled off the market. It cost Stryker $50 million to bring their facilities into federal compliance.
Recalls are nothing new to Stryker. One month prior to the Neptune recall, they recalled the ABG II Modular-Neck Hip Stems and the Rejuvenate Modulate – two systems for artificial hip implants. Three months before that, they issued an Urgent Field Safety Notice to hospitals and surgeons, alerting them to possible elevated risk of corrosion in these devices.
These devices are made with a titanium alloy blend comprised of titanium, zirconium, iron, and molybdenum. If corrosion occurs, metal particles can peel off, causing metal toxicity, or severe metallosis. The results can be detrimental, including tissue death, bone loss, and potentially damaging the liver, kidney, or other organs. As a result of this recall, several patients had no choice but to undergo expensive and painful surgeries to correct the defective devices.
A Stryker product lawsuit may entitle victims of Stryker’s defective devices to receive compensation. Several patients have already received settlements totaling millions of dollars, and these claims continue to grow rapidly. The attorneys at Pintas & Mullins are currently accepting defective Stryker product claims, especially for the Trident, Neptune, ABG II, and Rejuvenate devices.
Authored By: Renee Simmons. Renee is a journalist/blogger who contributes new legal information across different websites and organizations.