A medical device recall is when the manufacturer either removes a device or takes corrective action to address a problem with a device that is in violation of the FDA laws, such as when the device is defective and/or a risk to health.
These are some basic FAQs and resources to help you understand medical device recalls.
Who is responsible for recalling a medical device?
The manufacturer, distributor or other responsible party typically initiates a medical device recall.
Even though the FDA can require a company to recall a device, for example, when it receives enough complaints or it results in significant health problems, recalls are almost always voluntary and not mandated by the FDA.
There is no single agency responsible for recalls; this is a shared responsibility among four agencies. The FDA governs medical devices, such as hip replacement implants.
What is the FDA’s role with medical device recalls?
The FDA oversees a company’s product recall strategy and assesses the adequacy of it. In broad terms, steps taken by the FDA might include things such as:
How is the public notified about a medical device recall?
Information is posted in the searchable Medical Device Recall Database when:
In addition, the FDA may generate other communications such as press releases or other public notices about recalls, market withdrawals and safety alerts and does so when the public needs to be alerted about a serious hazard.
The public is not informed of all recalls via the media, but all recalls go into the FDA’s weekly Enforcement Report, which lists each recall according to classification and specific actions taken.
When a company recalls a medical device, such as a hip replacement implant, it generally issues a letter to physicians, insurance companies, patients and others as needed.
If a medical device has been recalled, do you need to stop using it immediately?
No, not necessarily. Sometimes a medical device just needs to be checked or adjusted. For instance, it might mean:
What if the medical device is implanted, such as a hip replacement device?
Devices that are implanted do not automatically need to be explanted. The first step is to have a conversation with your surgeon to better understand the reason for the recall. Then, the two of you can discuss your options and decide on the best course of action.
One thing to keep in mind, device manufacturers may structure recalls in such a way as to limit their legal liability, or ask patients to waive their right to a lawsuit. A recall may require that a patient takes a specific course of action in order to receive compensation, thus limiting treatment options.
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If you or a family member is suffering adverse effects from the use of a defective medical device, contact our legal team in Kansas City today for your free, no-obligation case evaluation. Your health may be at stake, and our lawyers want to help.
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