What prompted a recall?
Exactech claims it discovered (through testing) that polyethylene components used in the total ankle, hip, and knee replacement systems were packaged and stored in “non-conforming” vacuum bags. The purpose of the bags was to limit exposure of the polyethylene or plastic components while in storage to prevent deterioration due to exposure to oxygen.
The company says the vacuum bags were non-conforming because they did not contain a secondary barrier to increase resistance to oxygen. In return, this causes deterioration of the plastic components during storage. As a result, total knee, ankle, and hip manufactured between 2004 and 2022 using plastic components may not have been properly protected during storage. This can cause patients to experience premature wear of the plastic components and an increased risk of bone loss. The Exactech Connexion GXL polyethylene liner was taken off the market in 2019.
The recall notification referred to several clinical issues that could arise from deterioration of the polyethylene, including:
- Mechanical failure.
- Loosening of the device.
- Device fracture.
- Bone loss.
- Swelling of the affected area.
Exactech recalled all of its knee and ankle devices manufactured with polyethylene components using the non-conforming packaging. The Florida-based company also directed surgeons not to use the devices for future surgical procedures.