Exactech recently issued a class II recall for several of their products, which may affect thousands of people who received Exactech implant devices during knee or ankle replacement surgery.
But what exactly is a class II recall? And does that mean you should take action?
What is a recall?
A recall is when a product is taken off the market, generally because there is some defect or issue with the product that creates a safety concern for consumers or a liability for the company or companies that make the product.
A recall can be issued out of a company’s own accord, or the FDA can force a company to recall a product if it deems it appropriate.
In the process of being taken off the market, first the company must stop selling or distributing the product. Then, consumers must be made aware of the recall and given the opportunity for a refund.
But sometimes, a simple refund is not enough. Products are generally recalled for good reason, which means that there is the chance that someone, or multiple people, were hurt before the recall was issued.
When this happens, companies can be held responsible for the injuries and damages they cause to consumers. This means that the company would owe the injured consumer compensation that covers the expenses associated with their injuries as well as a refund.
A product liability lawyer can help you get this compensation.
What is a Class II Recall?
The FDA ranks recalls into classes. Each of these classes represents a different degree of danger, so to speak, with class I being the highest level of danger.
In a class I recall, there is a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Simply put, a class I recall is for a product that could potentially kill you if used in the manner intended by its producer. This is the highest class of recall issued by the FDA.
The second class is class II. The FDA defines a class II recall as:
“a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Class II is relatively broad, in terms of the level of danger posed by the product.
This is because of the phrasing, “medically reversible adverse health consequences.”
The Exactech Implant Recall
The Exactech recall is a class II recall because it fits into the definition of class II. The product, a device used in knee and ankle replacement implants, was recalled because it was packaged improperly. The improper packaging led to many devices wearing down earlier than they were supposed to, which will lead to adverse health consequences for many patients who received Exactech products during a replacement surgery.
The problem with the Exactech recall is that these adverse health consequences are technically reversible – but “reversing” these consequences means invasive surgery.
In order to fix the problem, patients who already had knee or ankle surgery will need to have surgery again to remove the recalled implant and have it replaced with a better one.
This process is not only highly invasive, but costly.
And while Exactech promises to pay patients for expenses directly related to this surgery, they do not account for secondary expenses, such as lost wages during procedures and physical therapy, financial restitution for pain and suffering, and more.
If you were affected by the Exactech recall, or by any medical device recall, contact the product liability attorneys at Merson Law PLLC at the number above or by filling out our quick contact form. We can help you get the maximum compensation possible for your class 2 recall, or for any recall that has affected you.