The OPTETRAK Comprehensive Knee System by Exactech is currently subject to a massive recall. All polyethylene implants used in knee and ankle arthroplasty that were sold in a certain style of vacuum bag are part of the Exactech recall. These bags failed to meet the criteria and may have allowed oxygen to enter, which could have harmed the liners in the devices. Patients who have already received a recalled device may require additional surgery to correct the problem. By 2022, Exactech had already warned surgeons on August 11 about the potentially widespread impact of the faulty bags.
Surgeons who have implanted Connexion GXL liners (or nonconforming standard UHMWPE liners) since 2004 may have damaged patients, according to a warning issued in August 2022. Before, only doctors who implanted GXL liners between 2015 and 2021 were cautioned. Discuss your Exactech lawsuit with a lawyer.
Class II recall is the category assigned by the FDA in the United States. This suggests that the product’s health effects will probably be minor and short-lived, or at least treatable by a doctor.
Inquire with your doctor if you had a total knee or ankle replacement since 2010 using components or inserts made by Exactech to see if your device is included in the recall.
After making this judgment, it’s time to talk to a personal injury attorney about your next steps.
Suit Against Exactech: The Flaws in the Exactech System
Joint replacements for the knee and the ankle use distinct components. The typical components of a knee replacement are as follows: Total Knee Arthroplasty Shared Example.
- The thigh bone’s metal attachment is called the femoral component.
- The tibial tray, or shin bone tray, is a metal insert.
- The patellar piece has a plastic attachment for the kneecap.
- The tibial polyethylene insert, or new knee joint cushion, is a plastic insert that slides in between the femoral component and the tibial component.
The three components of a typical total ankle replacement are as follows:
- A metal plate that fits over the shin bone (the tibial component).
- The talar element, an implanted metal rod that anchors to the talus (the big toe)
- The polyethylene insert, or plastic sleeve, is put between the tibial and talar components to act as a cushion or cartilage for the artificial ankle joint.