The U.S. Food and Drug Administration (FDA) announced recalls in August 2021 on Exactech knee, hip, and ankle replacements that contained polyethylene parts.
Packaging errors on joint replacement devices have been found to cause the oxidation of polyethylene parts.
This is a cause for concern because oxidation can degrade polyethylene inserts over time, leading to the potential need for revision surgery.
Implants dating back as early as 2004 are included in the Exactech recall.
Due to the sheer amount of implants included in the Exactech recall, coupled with the dangers these recalled devices may pose, lawsuits have been filed against Exactech across the United States.
Packaging errors on the device have been found to cause the oxidation of polyethylene parts:
- Oxidation can degrade polyethylene inserts over time, leading to the potential need for revision surgery.
- Exactech said that the degradation and premature wear of polyethylene inserts cause a “statistically significant” rate of failure in their implants.
Exactech Lawsuit Injuries
Exactech implants have been linked to various injuries and complications due to faulty packaging and defects in polyethylene parts.
Patients who received these defective implants may suffer from:
- Accelerated debris
- Bone loss from osteolysis
- Limited mobility or pain while walking
- Inability to bear weight
- Cracking, grinding, clicking, or other noises in the joint
- Joint swelling
- Instability
- Polyethylene wear
- Revision surgery because of osteolysis or polyethylene wear
These injuries can be debilitating and may require corrective revision surgeries, causing significant pain and disruption in the lives of affected individuals.
About Exactech (Company Background)
Exactech is a global medical device company located in Gainesville, Florida.
Founded in 1985, Exactech produces medical implants, instruments, and technologies related to joint replacements and joint replacement surgeries to be sold to physicians and doctors.
What Exactech Products Are Recalled?
According to the Exactech recall notice, the recalled products include various lines of ankle, hip, and knee implant components.
Recalled knee and ankle replacement product lines include:
- Optetrak;
- Optetrak Logic;
- Truliant;
- Vantage.
Recalled hip replacement products include liners from:
- Acumatch;
- MCS;
- Novation.
How Do I Know If I Have A Recalled Exactech Implant?
Many patients do not know how the implant used for their knee replacement, ankle replacement, or hip replacement was produced.
Many patients also don’t know whether the implant had a potentially faulty insert or was sealed in defective packaging.
We suggest asking your doctor or orthopedic surgeon for an updated copy of your medical records to determine the implant type and serial number.
From there, you can check the Exactech recall website to cross-reference your information with their recall documents.
How Many Exactech Lawsuits Have Been Filed? Current Status of the Exactech MDL
The Exactech MDL continues to grow, with over 1,800 pending Exactech Lawsuits filed as of January 2025.
New Exactech Lawsuits are currently being filed by lawyers across the country.