Defective Medical Device Issues: Class I, Class II and Class III Recalls
In Part Two of our series on defective medical device issues, we are talking about recalls. Implantable medical device recalls are common, and they can vary in terms of what they mean for patients. As the U.S. Food and Drug Administration (FDA) explains:
“FDA uses the term ‘recall’ when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
“A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed.”
According to the FDA, most medical device manufacturers recall defective implants voluntarily. However, the FDA has the authority to require recalls, and it will do in circumstances in which a defective device “is associated with significant health problems or death.” In other circumstances, however, a medical device manufacturer may attempt to limit or avoid a formal recall by choosing to no longer sell a medical device. These “silent recalls” are often referred to as “market withdrawals” by manufacturers.
Understanding the Differences Between Class I, Class II and Class III Medical Device Recalls
Depending on the severity of the issue that triggers a recall, the FDA will classify the recall as Class I, Class II or Class III. This is not to be confused with the classification of implantable medical devices themselves, which are also classified as Class I, Class II or Class III, but in reverse order in terms of the significance of their purpose. In other words, Class III medical devices (such as heart defibrillators and hip implants) are those that are designed to support or sustain human life; Class I recalls, however, present the greatest risk of death to patients.
The FDA describes Class I, Class II and Class III medical device recalls as follows:
- Class I – “A situation where there is a reasonable chance that a product will cause serious health problems or death.”
- Class II – “A situation where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.”
- Class III – “A situation where a product is not likely to cause any health problem or injury.”
The FDA maintains a database of medical device recalls, and our firm regularly publishes information about implantable medical device recalls as well. If you or a loved one has suffered serious or fatal medical consequences due to a recalled medical device, you may be entitled to significant financial compensation, and we encourage you to contact us promptly for a free initial consultation.
Coming Up in Part Three…
In Part Three of our five-part series on implantable medical device issues, we will discuss the significant limitations of the adverse event reporting system for defective medical device implants.
Discuss Your Legal Rights with a Florida Product Liability Lawyer at Searcy Denney
If you would like more information about the financial compensation that is available to individuals and families who have suffered due to implantable medical device defects, we encourage you to get in touch. For a free, no-obligation consultation with a Florida product liability lawyer at Searcy Denney, call us at 800-220-7006 or tell us how we can help online today.