You may have recently received a letter from your doctor who did your knee, ankle, or hip replacement regarding a recall of the device used for your replacement surgery. Exactech, the manufacturer of medical devices, has issued a recall for their knee, hip, and ankle joint replacement devices. Many of these devices have been implanted in patients in Tennessee. Those who have one of these devices may be eligible for compensation. The recall affects thousands of knee and ankle liners and inserts, and hip replacement liners. If you received a knee, hip, or ankle replacement with inserts or liners made by Exactech, it is essential to contact your doctor to determine if your device has been recalled, then contact GriffithLaw to discuss what rights and legal options you have to recover damages. Patients with the recalled devices may need to undergo revision surgery.
Understanding What Has Been Recalled
In 2021, Exactech began recalling some of its knee, ankle, and hip polyethylene inserts and liners used as replacement devices due to faulty packaging that could cause the device to wear out early. In 2022, the recall expanded to include approximately 270,000 products.
The problem with the defective packaging was that Exactech’s inserts became exposed to oxygen. This causes the devices to deteriorate and wear out earlier than they should—causing injury to the patient. Once the plastic insert or liner deteriorates, there is no longer cushioning for the joint to absorb impact, and the patient may experience serious injury or pain. Patients with these devices may need revision surgery to replace the defective liner or insert to correct the issue.
This recall is classified as a Class II recall by the U.S. Food and Drug Administration. A Class II recall means that the recalled product does not pose an immediate risk of death or serious injury but could cause a health or safety risk. Some possible consequences of the recalled Exactech liners or inserts include:
- Early device failure
- Bone loss
- Fracture of the implanted component
- Revision surgery
The recalled items include knee and ankle polyethylene inserts sold under specific brand names such as OPTETRAK, Custom OPTETRAK, Truliant, and Vantage. The recall also includes Connexion GXL and Conventional hip liners. To determine if your specific device is being recalled, you will need to check the serial number, which can be done using Exactech’s Recall Serial Number Checker. If you do not have the serial number for your device, contact the doctor who performed your replacement surgery.
Signs of Possible Exactech Device Failure
If you notice any of the following symptoms that may indicate a failure of your knee, ankle, or hip device, contact your surgeon immediately:
- Pain when walking
- Swelling that is new or worsening
- Grinding sound in your ankle or knee
- Difficulty bearing weight
- Feeling unstable
To determine if the device is failing, your surgeon will do an examination and order imaging tests such as x-rays or an MRI to evaluate the condition of the insert or liner.
What to Do if You Have a Recalled Item in Your Body
If you have a recalled Exactech device in your body, you need to contact an attorney as soon as possible. Most lawyers, including GriffithLaw, offer a free initial consultation to discuss your case, so you have nothing to lose by contacting a lawyer.
Since those with recalled devices may need revision surgery, you will want to make sure you do not have to cover the cost. When you use our team of lawyers at GriffithLaw, you can be guaranteed that we will work to protect your legal rights and make sure you get the total amount of compensation you are entitled to receive.
Don’t wait to take legal action since there may be a limit on the time you must file a claim. If you wait too long, your case could be dismissed, and you will not be able to recover damages.
To schedule a no-obligation consultation with GriffithLaw, contact us online or call us at 615-823-8233. We work on a contingency fee basis, so you are not required to pay any upfront costs in order to pursue a claim. We charge no fee if there is no recovery.
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