Surgeons in the United States received an Exactech recall letter in February 2022 that detailed problems with certain knee and ankle implants packaged in “non-conforming” bags.
According to the letter, each of the recalled Exactech knee or ankle replacements contained a polyethylene plastic insert which was placed in a defective vacuum bag. These “non-conforming bags” did not contain another barrier layer of ethylene vinyl alcohol (EVOH), which provides critical oxygen resistance for the implant.
Consequently, the Exactech poly recall was issued because the ineffective bags may have allowed oxygen to diffuse the plastic inserts, resulting in oxidation during storage or before the joint replacement surgery, putting those getting these replacements parts at risk for:
- Bone loss
- Loosening, pain, and lysis after a knee replacement
- Degrading Exactech plastic inserts
- Accelerated knee wear debris
- Fractures
- Cracking
- Premature knee revision surgery
- Component fatigue
What are the Exactech Ankle and Knee Devices that Have Been Recalled?
Initially, the recall only included a limited number of Exactech knee replacements. However, the manufacturer has now widely expanded the recall to include all the Exactech polyethylene inserts shipped with knee and ankle implants in non-conforming bags.
As a result, the implants that have been impacted by the Exactech Poly Recall include:
- Exactech Optetrak
- Exactech Optetrak Logic
- Exactech Truliant knee systems
- Exactech Vantage ankle system
What Can You Do If You Were Impacted by This Recall?
If you discover that you or a loved one have a defective Exactech replacement part, you may be able to pursue a lawsuit for compensation for the problems caused by your defective Exactech implant.
To help you determine if pursuing these monetary damages is an option, you should reach out to a medical device attorney. These lawyers can provide a consultation to explain if you qualify to file an Exactech recall lawsuit.
