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How Does a Recall Work for a Defective Medical Device?

December 28, 2021

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When a defective medical product is on the market, it can be very dangerous, depending on the type of device it is and the nature of the defect. In extreme cases, the defect can cause serious injuries and fatalities. When a medical device manufacturer or distributor learns that a product is defective or does not meet safety standards by the Food and Drug Administration (FDA), they have a responsibility to issue a recall warning and to initiate the recall process. 

Oftentimes, when a company becomes aware that a medical device is defective in some way, they will issue the recall voluntarily rather than waiting for the FDA. It is important to understand that there are different types of defective medical product recalls, which will depend on the severity of the issue.

According to the FDA, a recall refers to the action taken by a manufacturer to address a problem or defect of a product. A product recall will occur when a device is defective, if it poses a health risk, or if it is both defective and poses a health risk. Depending on the nature of the problem, the manufacturer may correct the problem by addressing the issue in the place where the product is used or sold. If the problem is more serious, the manufacturer may remove the device from where it is used or sold.

What Are the Different Types of Medical Device Recalls?

There are three categories of medical device recalls, including the following:

• Class III recall: This is the most common type of product recall, and it is also the least serious. These products generally do not pose any health hazards. However, they are considered a defective product if they are in violation of FDA regulations.
• Class II recall: With these defective medical products, there is a serious risk of injury or death, but the risk is not imminent. A Class II recall is preventative in nature and is meant to protect patients against injuries in the future. The FDA will work with the product manufacturer to recall the defective products and will develop a plan to notify consumers and pull the product from the market.
• Class I recall: This is the most serious type of recall, as there is an immediate risk of serious injury or death associated with the defective medical product. This type of recall is rare, and it warrants immediate action to remove the product from the market and from consumers’ homes. The FDA will work closely with the manufacturer to ensure that the recall is comprehensive and that the recalled products are trackable.

What Is the FDA’s Role in the Recall Process?

The product manufacturer is responsible for taking the necessary steps to issue a recall for a defective medical product. However, the FDA will oversee the company’s recall strategy and determine whether additional steps need to be taken. The agency may also do the following:

• Assess the health hazard associated with the defective product.
• Review the company’s action plan to ensure that they are addressing the problem effectively.
• Determine whether the product violates FDA law.
• Assign the recall Class I, Class II, or Class III based on the relative degree of risk.

How Do Companies Issue a Recall for a Defective Medical Device?

When a company learns that a medical device is defective, they must notify the appropriate FDA District Office immediately. The company must include the name of the product, a detailed description of the defect, information about the estimated quantity of products affected, and a proposed recall strategy.

Once the FDA has received this information, they will conduct a thorough review, determine the product’s health hazard, assign a recall classification, and make revisions to the company’s recall strategy. At this point in the process, it is the recalling company’s responsibility to notify all parties who may be affected by the recall. In most cases, the company will send a letter that identifies the defective product, describes the nature of the defect, and provide detailed instructions on the next steps. 

In addition, the company is responsible for providing the FDA with status updates every two to four weeks. The recall will continue until the FDA finds that the company made every effort to remove the product or correct the defect. At this point, the FDA will issue a written notice that the recall has officially been terminated. 

The process of identifying defective devices can be challenging, particularly when there is a large volume of products and some refuse to send the products back or reply to the notification. In addition, the information available to identify specific devices is somewhat lacking. Recalls are generally reported in lot numbers, which may differ from manufacturer to manufacturer. The workers in charge of pulling inventory may need to go through tens of thousands of lot numbers included in the recall notification.

What Are Examples of Commonly Recalled Medical Devices?

The following are examples of products that have been recalled due to the health risks that they pose to patients:

• • Hip replacements: There have been a number of metal-on-metal hip replacement devices that were recalled after a small amount of metal was released into the tissue of the surrounding hip implant. The resulting injuries ranged in severity, but many patients suffered cobalt toxicity and metallosis.
  • Knee replacements: The metal-on-metal knee replacement devices cause some of the same health issues as the defective hip replacements, including implant failures and metal poisoning. Other devices used cement, which has been known to deteriorate over time and break off. 
  • Surgical mesh: This device is used for hernia repair and vaginal repair surgeries. It has been known to cause a range of health issues, including mesh erosion and organ perforation, and it can require additional surgeries to remove the device and replace it with a safe, more effective product.

• Pacemakers, defibrillators: In 2005, the FDA issued a nationwide recall of certain implantable defibrillators and cardiac resynchronization therapy defibrillators. 

What Should I Do if My Implanted Device Has Been Recalled?

In some cases, a defective medical device simply needs to be checked or adjusted. Even a device that has been implanted does not necessarily need to be removed. However, it is highly recommended that you speak to your health care provider about your concerns. They will be able to explain the reason for the recall and determine the best course of action going forward. For example, your surgeon may suggest that you hold off on removing the hip replacement device if you are not experiencing any pain, swelling, or discomfort. However, if you are experiencing any of these symptoms, the device may need to be removed immediately.

How Can a Lawyer Help Me?

Defective medical devices can cause very serious injuries. It is important to understand that device manufacturers often structure recalls in a way that limits their legal liability. In some cases, they ask patients to waive their rights to take legal action. If the recall requires you to take a specific course of action to receive compensation, this could limit the treatment options that are available to you. A lawyer will work closely with you to determine the severity of your injuries and determine if you are eligible for compensation, including all medical expenses related to the injury, lost wages, and pain and suffering.

Philadelphia Defective Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler Represent Clients Injured by Faulty Medical Products

If you have been harmed by a recalled medical product, our Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler can explain your legal options. To schedule a free consultation, call us at 215-569-4000 or contact us online. Located in Philadelphia, we serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County.