A total of 147,732 Exactech Knee and Ankle Implants have been recalled by Exactech as of April 7, 2022, because the devices were packaged with vacuum packaging that was not “up-to-specs” which allows oxygen to get to the devices thereby permitting oxidation of the product. Oxidation over time causes accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to the need for corrective revision surgery. Some studies have demonstrated that these implants wear out as much as seven times as fast as comparable implants. If you have had to have one of these implants revised or you currently have one, you should speak to a lawyer about the Exactech recall and learn what a voluntary recall means to you.
The Exactech Recall and Continued Sale of Products
You would think that after a company identifies and problem necessitating a recall of their medical product, they would cease shipping anything that might be affected. Exactech did not do this. On August 31, 2021, Exactech issued a recall of their Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts produced since 2004. However, they continued to ship some products with defective packaging at that time for medical use. On April 7, 2022, by way of a letter, they expanded the Exactech recall to include implants that were packaged and shipped to medical professionals for implant after August 31, 2021. This expansion encompassed over 50,000 additional devices that had been shipped for medical use!
Exactech Implants Wearing Out Early
The April 7, 2022 letter by Exactech indicated that after extensive research and studies, they determined that the implants were packaged and sent out in packaging that failed to include a second barrier to oxidation. The bags need a layer with ethylene-vinyl alcohol to protect against oxidation, and for the past roughly two decades, Exactech’s manufacturing process failed to include that second layer. Oxidation of the implants and their components, in turn, can result in these implants cracking or failing as well as accelerated knee wear and bone loss. The letter also admits that studies have shown the need for revision and/or repair of these devices to be 3-7 times higher than comparable products.
What Symptoms Should People With Exactech Implants Watch For?
Symptoms to watch for in a failing knee or ankle replacement implant include:
- New or increased knee or ankle pain
- Inability to bear weight
- Grinding or other noises
- Swelling in the knee or ankle
- Instability of the knee or ankle.
Which Exactech Products Are Included in the Recall?
The products covered by the Exactech recall include Optetrak, Optetrak Logic, Truliant, and Vantage inserts and components sold from 2004 up to April 7, 2022. Specifically, the recall involves:
- Exactech Optetrak CR Tibial Components
- Exactech Optetrak PS Tibial Components
- Exactech Optetrak CR Tibial Inserts
- Exactech Optetrak CR Slope Tibial Inserts
- Exactech Optetrak PS Tibial Inserts
- Exactech Optetrak HI-FLEX PS Tibial Inserts
- Exactech Optetrak Logic CR Tibial Inserts
- Exactech Optetrak Logic CR Slope Tibial Inserts
- Exactech Optetrak Logic CRC Tibial Inserts
- Exactech Optetrak Logic PS Tibial Inserts
- Exactech Optetrak Logic PSC Tibial Inserts
- Exactech Optetrak Logic CC Tibial Inserts
- Exactech Truliant CR Tibial Insert
- Exactech Truliant CR Slope Tibial Insert
- Exactech Truliant CRC Tibial Inserts
- Exactech Truliant PS Tibial Inserts
- Exactech Truliant PSC Tibial Inserts
Check To See If Yours is Recalled
Exactech has been manufacturing these since the 1990s but they believe that packaging issues only affect products packaged from 2004-2022. You can go to the Exactech website and check the serial number to see if your implant is covered by the Exactech recall. These numbers are generally kept in the medical records of the surgery center or surgeon.
Talk to an Exactech Implant Recall Lawyer
The company has offered to refund and pay some of the costs associated with the recall. But in light of the defective packaging that was used for roughly 18 years before they finally stopped altogether, you would be very wise to speak to a product liability lawyer regarding your defective knee or defective ankle implant before even considering any offer to pay your “expense.” If you have received one of these implants and suffered from failure or are having ongoing issues, talk to a knee replacement lawyer about your recalled Exactech knee or ankle implant to learn what compensation for your pain, suffering, medical, expenses, and other damages you may be entitled to.
Author
