In 2021, Exactech released the results of its tests, indicating that there is a defect in the inner layer of the bags in which the plastic inserts of some of its devices are stored.
This defect allows for air to leak into the bags and come into contact with the device. This is known to start the oxidation process, which can damage the integrity of the component.
For example, in its updated recall notice, Exactech indicates that the oxidation process of certain types of plastic inserts can “severely degrade” the insert.
Patients with the affected insert may experience significant pain and swelling or may require corrective surgery.
Exactech indicates that these plastic inserts for its knee and ankle replacement devices manufactured since 2004 were stored in the defective packaging.