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What Should Patients Know about Medical Device Recalls?


When you schedule a replacement surgery, you expect everything to go according to plan. You expect your anesthesiologist and surgeon to do their jobs professionally, and you expect to receive the postoperative care you need to recover as quickly as possible.

But, you probably don’t give much thought to the replacement device itself. Most patients assume that these devices are safe and well-tested, and that they will work as intended for years to come.

Unfortunately, this is not always the case. In fact, medical device failures are alarmingly common. Medical device manufacturers issue recalls every year; and, while these recalls prevent some patients from receiving defective devices, for many patients it is already too late.

7 Important Facts about Medical Device Recalls

If you have a medical device that is subject to a manufacturer or U.S. Food and Drug Administration (FDA) recall, what do you need to know? Here are seven important facts about medical device recalls:

1. There are Different Types of Medical Device Recalls

Medical devices get recalled for different reasons, some of which are more concerning for patients than others. The FDA divides medical device recalls into three classifications:

  • Class I – Class I recalls are the most serious. With a Class I recall, the FDA has determined that there is a “reasonable chance” that the defective medical device will cause serious health problems or death.
  • Class II – A Class II recall can mean one of two things. Either (i) the device “may cause a temporary or reversible health problem,” or (ii) “there is a slight chance that it will cause serious health problems or death.”
  • Class III – Class III recalls are the least serious. The FDA issues these recalls when a medical device, while defective, is not likely to cause any health problem or injury.

According to FDA data, the substantial majority of medical device recalls (approximately 92 percent) are Class II. The remaining eight percent are split about evenly between Class I and Class III. All three classes of recalls may result in “removal” of the device from the market or “correction” of the issue that has been identified. In most cases, manufacturers determine what is necessary based on the nature of the defect and the remedial options (if any) that are available. However, if a manufacturer refuses to take appropriate action, then the FDA may issue an order compelling removal or correction.

2. Recalls are Not Always (or Even Often) Timely

By their nature, medical device recalls often come when it is already too late. In other words, in most cases, thousands of patients (if not tens or hundreds of thousands of patients) already have the defective devices in their bodies.

When issuing medical device recalls, manufacturers and the FDA will usually provide guidance for patients. This guidance can range from monitoring for potential symptoms to consulting with their doctors to seeking revision surgery (more on this below). Ultimately, however, patients need to make their own decisions with their own best interests in mind—and those who have concerns should not hesitate to seek medical advice.

3. Recalls are Particularly Common with Certain Types of Medical Devices

While virtually all types of medical devices can be (and have been) subject to recalls, recalls are particularly common with certain types of medical devices. This includes implantable joint replacement devices, such as hip, knee and ankle replacements. Some recent examples include:

  • Exactech Hip Replacement Device Recall – Exactech has recalled its hip implant devices due to an issue identified with these devices’ “ultra-high-molecular-weight polyethylene” plastic. This plastic can degrade over time, causing device failure, infections and other health problems.
  • Exactech Knee Replacement Device Recall – The Exactech knee replacement device recall arose out of concerns related to improper packaging. The improper packaging can result in oxidation causing premature wear and failure.  
  • Exactech Ankle Replacement Device Recall – Exactech has also recalled its ankle replacement devices due to the same concerns that triggered the company’s hip implant device recall.

Other recent examples include Stryker’s recall of its Accolade TMZF, Rejuvenate and ABG II devices and DePuy’s recall of its ASR XL devices.

4. Revision Surgery May (or May Not) Be Necessary

Some patients who receive defective medical devices will need revision surgery, and some will not. Whether revision surgery is necessary largely depends on two factors: (i) the nature of the defect, and (ii) how the body responds to the defect. If a defect causes total device failure, then revision surgery will almost certainly be necessary. In other cases, doctors may recommend monitoring patients’ symptoms before deciding whether to undergo a second procedure.

5. Manufacturers Don’t Tell You Everything You Need to Know

While medical device recalls often include lots of technical information about the devices involved, they don’t tell patients everything they need to know. For example, recall notices will often recommend that patients contact the company to obtain a refund or schedule delivery of a replacement device. However, medical device defects can leave patients with substantial physical, financial and psychological costs, and patients will be able to sue manufacturers to recover these costs in many cases.

6. Patients Who Receive Defective Medical Devices are Entitled to Just Compensation

Lawsuits involving defective medical devices are governed by the law of product liability. Under this law, manufacturers are “strictly liable” for patients’ losses—meaning that proof of negligence is not required. Patients who have defective medical device lawsuits can seek just compensation for their current and future losses. This includes medical expenses, job loss, pain and suffering, and emotional trauma, among others.

7. Even if Your Medical Device Hasn’t Been Recalled, It Could Still Be Defective

Finally, as a word of caution, not all defective medical devices get recalled. If you have any concerns related to a medical device, you should consult with your doctor. If your doctor identifies an issue with your device, then you should consult with a lawyer as well—as you may have a claim for financial compensation.

Discuss Your Legal Rights with a Medical Device Lawyer at Searcy Denney

If you have questions about your legal rights related to a medical device defect, we encourage you to contact us for more information. Please give us a  call or send us a message online to schedule a free initial consultation.



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