Have you or a loved one received a total knee or ankle replacement using a Exactech OPTETRAK Comprehensive Knee System?
If so, your medical device may be part of the FDA’s Class II Recall and you may be owed compensation.
What is the Exactech OPTETRAK Comprehensive Knee System Recall About?
Exactech, the maker of the OPTETRAK Comprehensive Knee System, issued an URGENT medical device correction in Feb 2022. The United States Food and Drug Administration (FDA) has classified this recall as a ‘Class II Recall.”
This means that the FDA has determined that exposure to the product may result in medically reversible or temporary health consequences.
What is the Problem with Exactech OPTETRAK Comprehensive Knee Systems?
The manufacturer found that one of the layers used in packaging for the polyethylene insert used in both the total ankle replacement and total knee replacement systems failed to conform to specifications.
The company further found that this layer is capable of allowing oxygen from the air to diffuse into the plastic prior to surgical implantation in the ankle or knee. This may result in oxidation, leading to premature failure of components, damage, and injury to the patient.
Absent this plastic insert, there is a lack of cushioning to absorb the impact of movement, resulting in injury and pain.
What Products are Included in the Exactech OPTETRAK Recall?
The recall includes all ankle and knee arthroplasty polyethylene inserts that were packaged in vacuum bags deemed to be non-conforming with specifications, regardless of the product’s labeling or shelf life.
Defective Devices and Components Include but Are Not Limited To:
- OPTETRAK® Tibial Inserts
- OPTETRAK® All-polyethylene Tibial Components
- OPTETRAK Logic® Tibial Inserts
- VANTAGE® Fixed-Bearing Liner Component
- TRULIANT® Tibial Inserts
*Since 2004, more than 60,000 devices and components have been implanted in affected patients across the United States
What Types of Symptoms Are Associated with Exactech Ankle or Knee Failure?
- New or worsening swelling
- New or worsening inflammation
- Pain or discomfort when walking
- Inability to comfortably bear weight on that ankle or knee
- Grinding or other noises when ankle or knee joint is mobile
- Instability and/or imbalance
- Clicking noises in the knee or ankle
How Much is a Exactech Knee and Ankle Recall Lawsuit Worth?
Every individual’s case and circumstances are unique, affecting any potential verdict or settlement. Although no verdicts or settlements have yet to be reported, using information from hip replacement cases, we can make an educated guess that similar amounts, ranging between $100,000-$250,000 may be applicable per person.
Who Qualifies for an Exactech Knee and Ankle Recall Lawsuit?
Any individual who underwent knee or ankle replacement surgery since 2004, who had any of the products mentioned in this article surgically implanted, may be eligible to seek compensation for injury and damages.