Exactech Recalls Ankle Devices After Concerns Of Plastic Degradation
Exactech Recalls Ankle Devices
On August 30, 2021, Exactech, a medical device company, initiated a Class 2 recall of their Vantage Total Ankle System due to concerns that improper packaging compromised plastic components of these medical devices. The Exactech ankle system includes a polyethylene (plastic) insert that sits between the tibial and talar components. When shipped and stored, these polyethylene components should be packaged in double-layered, oxygen resistant vacuum sealed bags. Exactech, however, discovered that its Vantage Ankle System components were improperly packaged without the second layer. The out-of-specification packaging permitted oxygen to reach the polyethylene components, resulting in potential degradation of the plastic.
Degradation of these important plastic components can lead to serious health problems for patients that have received the Vantage Ankle System. For example, the compromised plastic components may lead to premature device wear, cracking, and damage to the bone, which may necessitate revision surgery. Patients should consult with their surgeons if they are experiencing any new or worsening ankle swelling, pain while walking, inability to bear weight, grinding or clicking, or instability in the ankle.
Contact a Product Liability Lawyer at Burg Simpson for Help Now
If you are a loved one has suffered an injury and/or required a revision surgery after being implanted with an Exactech Vantage Total Ankle System, contact one of the experienced product liability attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call (888) 895-2080 or fill out our contact form for a FREE no-obligation consultation today.
Over the past four decades, Burg Simpson’s team of product liability attorneys has helped victims who suffered from injuries due to dangerous products. Our team will begin by conducting a thorough investigation into the specific of your case. The product liability lawyers at Burg Simpson help injured clients obtain justice and the compensation they deserve.