Exactech Recall Lawsuit
In June 2021, Exactech, an orthopedic device company, recalled some of its total hip, knee, and ankle replacement devices or components.
Exactech medical device recall was issued in the summer of 2021, and the recall is ongoing as of February 2022.
When Was the Exactech Recall Issued?
Exactech initiated the recall in August 2021. As of February 2022, the recall is still in effect and has expanded to include a broader range of inserts.
Why Is Exactech Recalling Its Medical Devices?
In 2021, Exactech released the results of its tests, indicating that there is a defect in the inner layer of the bags in which the plastic inserts of some of its devices are stored.
This defect allows for air to leak into the bags and come into contact with the device. This is known to start the oxidation process, which can damage the integrity of the component.
For example, in its updated recall notice, Exactech indicates that the oxidation process of certain types of plastic inserts can “severely degrade” the insert.
Patients with the affected insert may experience significant pain and swelling or may require corrective surgery.
Exactech indicates that these plastic inserts for its knee and ankle replacement devices manufactured since 2004 were stored in the defective packaging.
What Devices Are Included in the Exactech Medical Device Recall?
Included in Exactech’s recall is the polyethylene (plastic) insert used in its total ankle replacement and total knee replacement devices.
Exactech also issued a warning about its total hip replacement device; however, not all devices are being recalled.
Recalled Ankle Replacement and Knee Replacement Devices
Patients can use a search tool on Exactech’s website to determine if their implant is among those being recalled. To do so, you will need the serial number for your device, which you can get from your surgeon.
The recall of the Exactech total ankle and replacement plastic inserts and components includes:
- OPTETRAKⓇ All-polyethylene CR and PS Tibial components devices;
- OPTETRAKⓇ CR Tibial Inserts;
- OPTETRAKⓇ HI-FLEXⓇ PS Tibial Inserts;
- OPTETRAKⓇ LogicⓇ series of Tibial Inserts;
- TRULIANTⓇ CR, CRC, PS, and OSC Tibial Inserts; and
- VANTAGEⓇ Fixed-Bearing Liner Component.
Please note that this is not a list of every recalled Exactech medical device. To find out if your implant or one of its components is included in the recall, you can contact your surgeon and use the search tool on Exactech’s website.
Total Hip Replacement Device Advisory
According to tests conducted by Exactech, the Connexion GXL liners in its hip replacement devices also led to increased risks.
For example, Exactech reports that these devices prematurely wear out, potentially requiring the patient to undergo corrective surgery to remove or revise the implant. Further, the device may not wear out evenly, which can increase the severity of the damage to the bone and the implant.
What Does the Exactech Recall Mean for Me?
You can use the search tool on Exactech’s website to determine if your medical device is part of the recall. You can also contact your doctor to get additional information about your implant, such as the serial number.
Currently, Exactech is advising doctors against prematurely removing the device from their patients if the patient is not experiencing symptoms. That said, you should note any symptoms that you are experiencing and stay in contact with your doctor.
Contact your doctor right away if you start or continue experiencing swelling, pain, clicking, or grinding in your knee, ankle, or hip replacement.
What Should I Do If I Have a Recalled Exactech Implant?
Exactech provides a helpline on its website to help patients find out if they qualify for reimbursement for their out-of-pocket expenses; however, you may be eligible to receive more.
If you received the recalled Exactech medical devices, you can also contact an attorney to determine if you have a personal injury claim against Exactech for your condition.
If you are uncertain if you qualify, you still benefit from contacting a medical device injury attorney.
The lawyer can help you find out if you can recover damages from Exactech in or outside the courtroom. Additionally, you may have to file an Exactech claim before a certain amount of time, so contacting an attorney as soon as possible is important.
Call the Defective Medical Device Attorneys at Boucher LLP
Boucher LLP has been helping patients like you receive compensation for over 30 years. Our defective medical device attorneys provide compassionate, zealous advocacy for our clients on their journey to justice.