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Our attorneys are handling claims for victims seeking to file an Exactech recall lawsuit in all 50 states.
Exactech is a major manufacturer of orthopedic implants used in joint replacement surgery. Exactech is now recalling all of its implants that were used in total ankle replacement procedures since 2016.
These implants are being recalled because a packaging defect has made them susceptible to premature failure causing patients to suffer severe pain and undergo corrective surgery.
Our national product liability lawyers are accepting new Exactech recall lawsuit cases from anyone who had an Exactech ankle implant that prematurely failed.
About the Exactech Ankle Implant Recall
Based in Gainesville, Florida, Exactech Inc. is one of the world’s leading manufacturers of orthopedic surgical implants. The company specializes in making implant systems for joint replacement surgeries such as knee, hip and ankle replacements.
The Vantage Total Ankle System is Exactech’s implant for total ankle replacement surgeries. The Vantage implant system was first released on the U.S. market in 2016 and since then it has been used in thousands of total ankle replacement procedures. Anyone with a total ankle replacement done after 2016 may have a Vantage system implant in their ankle.
In February 2022, Exactech initiated a comprehensive recall of all its Vantage ankle replacement systems (and all of its knee replacement implants). The recall came after Exactech discovered that there was a major flaw in the vacuum-seal packaging it was using for critical plastic insert components of the ankle implant system. The plastic inserts are designed to absorb friction and wear between the moving metal parts of the implant.
The packaging for these inserts was supposed to be air-tight to prevent the plastic material from becoming too brittle before being inserted. In 2021, Exactech realized that the packaging it was using was not air-tight at all due to a missing layer. This defect allowed oxygen to pass through the packaging causing the plastic inserts to oxidize and become too brittle before they were used in a patient. This hidden flaw made Exactech’s ankle replacement system prone to early failures.
Exactech Recall Letter to Doctors
On February 7, 2022, Exactech sent orthopedic surgeons a letter explaining that they conducted “extensive testing” and confirmed that most of their inserts (ankle and knee) manufactured since 2004 were packaged in “out-of-specification” or “non-conforming” vacuum bags that did not contain the necessary “secondary barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance.” The letter from Exactech went on to state:
The use of these non-conforming bags may enable increased oxygen diffusion to the UHMWPE (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation of the material relative to inserts packaged with the specified additional oxygen barrier layer. Over time, oxidation can severely degrade the mechanical properties of conventional UHMWPE, which, in conjunction with other surgical factors, can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.
The letter from Exactech instructed doctors to immediately stop using all Exactech ankle and knee replacement implant systems. Exactech also instructed doctors to return any Exactech implants in their inventory for replacement with new devices. Exactech also provided doctors with a draft letter to send to all patients with Exactech implants in their knee or ankle.
Beyond sending this letter to its own contact list of orthopedic surgeons (which is presumably drawn from sales records), it is not clear if Exactech has taken any other affirmative steps to notify patients about the recall. The defective Exactech implants have been surgically implanted in an estimated 147,000 patients over the last decade. Many of these patients remain unaware of the recall.
What Are the Symptoms of Premature Ankle Implant Failure?
The recalled Exatech ankle implant systems have a very high rate of premature failure. This means that the implant becomes non-functional within just a few years (or less) after being implanted. When an ankle implant fails it will cause pain, swelling, and instability in the joint. These symptoms will gradually get worse over time as the plastic inserts continue to deteriorate.
The pain, swelling, and mobility issues caused by premature failure of an Exactech ankle implant system eventually force the patient to undergo one or more revision surgeries. These surgeries involve the replacement of the joint implant system and they can be very painful and leave the patient unable to work or walk while they recover.
Exactech Ankle Implant Recall Lawsuits
As a manufacturer of surgical implant devices, Exactech has a legal duty to ensure that its products are safe and effective when used for their intended purpose. This includes an obligation to ensure that products do not contain hidden defects that make them likely to malfunction and cause injury. Exactech’s formal recall is effectively an admission that its ankle implants were defective. This means that Exactech can be held legally liable for any injuries, pain & suffering, and financial losses caused by premature failure of an ankle implant.
Patients with the Exactech Vantage ankle replacement system implanted during their surgery can potentially bring an Exactech recall lawsuit if their ankle implant fails prematurely. If the premature failure of the Exactech ankle implant required corrective surgery, the patient would be entitled to damages for pain and suffering, the medical expenses of the revision surgery, and lost income.
Contact Us About an Exactech Ankle Implant Recall Lawsuit
If your Exactech ankle replacement implant failed and you had to undergo corrective surgery, our lawyers can help you. Call our law firm today at 800-553-8082 or get a free online consultation today to see if you have a case.