In February 2022, the Food and Drug Administration (FDA) issued recalls of several knee and ankle replacement devices produced by the medical device manufacturer, Exactech.
These recalled devices were implanted in patients starting in 2004 and continuing even as late as 2022.
The affected components of the implants are inserts made of polyethylene, a type of plastic, which was packaged in non-conforming vacuum bags.
This packaging error resulted in the inserts becoming oxidized, allowing them to degrade earlier than anticipated or become damaged once implanted into a patient’s body.
Exactech’s recalled devices include certain implants used in total knee replacements and total ankle replacement procedures that included the Exactech Knee and Ankle Ultra-High Molecular Weight Polyethylene component.
This encompasses Exactech OPTETRAK®, OPTETRAK Logic®, and TRULIANT® tibial inserts and components, in addition to VANTAGE® fixed-bare lining components.