The Food and Drug Administration will recall a medical device when it is found to pose serious risks to public health that outweigh any advantage gained by the use of the product. The recalled devices may violate federal law, may be defective, or may be a risk to health. Some devices were manufactured incorrectly, and the manufacturer may not be aware which lots were defective, forcing it to recall the entire product.
The types of actions the FDA may impose on a manufacturer may include requiring re-labeling, notifying patients of a potential problem with the device, and monitoring patients for potential health issues associated with the device.
The recall may be related to a correction on a device or total removal of the device from the market.
Most manufacturers voluntarily recall medical devices that are found to have created health risks, but the FDA has the right under law to issue the recall if the company does not do so, or refuses to do so, which is rare.
In most cases, the recalls are voluntary and take place after the device has been associated with many adverse events.
Many medical device recalls occur every year. These recalls include medical devices implanted in a patient, used in surgery or other medical treatment, in vaccines, blood and other biologics. Some medical device recalls are associated with patients that suffered extreme damage or death. Certain metal-on-metal hip and knee replacement implants were later found to be dangerous to human health when metal was released into the body. Another surgery to remove and replace the dangerous implant was often required, and the patient may have suffered permanent damage or was a high-risk surgical patient due to age or other health conditions.
Commonly Recalled Medical Devices
Several brands of metal-on-metal hip and knee replacements were recalled when small amounts of metal were released into the tissue surrounding the implant. The level of injuries to patients varied, but in many cases was very serious. The companies recalling devices include DePuy, Stryker, Portland Orthopaedics, and Zimmer.
Talk to your surgeon and find out what device was used in your surgery if you are suffering from problems with a hip replacement.
Metal on metal knee replacement devices were found to be a health risk when small pieces of metal were released into the tissue that were toxic to the body, causing serious adverse events. Other knee replacements were put in place with cement, which can deteriorate over time and break off. Newer devices may not have included the use of cement, but have come loose.
Surgical mesh is used for various types of surgeries, including hernia repair and vaginal repair. The mesh has been associated with various health problems and may require additional surgeries to remove the product and replace it with a safer product.
If You Need A Lawyer for Medical Device Lawsuit
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