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Understanding The Exactech Recalls and  Lawsuits

Jul 19, 2022
Shamis & Gentile, P.A.
Understanding Recalls and Lawsuits

In February 2022, Exactech, a manufacturer of widely used orthopedic implants, issued an urgent recall on several of its products. The recall, which initially only included the OPTETRAK Comprehensive Knee System, has been extended to include all knee and ankle arthroplasty inserts packaged in non-compliant vacuum bags (regardless of label or shelf life). The reason for the recall was the non-compliant packaging of the devices could lead to product failure, resulting in further injury and the need for revision surgery.

If you received a total knee or total ankle replacement since 2010, with components manufactured by Exactech, you should contact your physician or surgeon to see if your device is affected by the recall. If it is, you should contact a personal injury lawyer to discuss your case.

What Knee and Ankle Replacements are Part of the Exactech Recall?

The affected components include the following:

  • OPTETRAK® All-polyethylene Tibial Components
  • OPTETRAK® Tibial Inserts
  • OPTETRAK Logic® Tibial Inserts
  • TRULIANT® Tibial Inserts
  • VANTAGE® Fixed-Bearing Liner Component

Since 2004, over 85,000 of these components have been used in knee or ankle replacements in the US. 

The Problems with the Exactech Devices

Exactech found that one of the packaging layers for the polyethylene inserts used in knee and ankle replacements did not conform to specifications. As a result, the devices are not thoroughly protected and oxygen could diffuse into the insert while it is on the shelf. The resulting oxidation can cause the components to wear out prematurely, causing damage to the plastic, even after it has been implanted in the patient’s body. When these inserts break down, there is no cushioning to absorb the impact of motion, and patients may experience pain and further injury.

What are the Symptoms of an Exactech Knee or Ankle Failure?

If the Exactech implants break down prematurely, the following symptoms may present:

  • Ankle swelling – either new or worsened
  • New or worsening knee swelling
  • Pain while walking
  • Inability to bear weight
  • Grinding or clicking in the knee or ankle
  • Instability

Your surgeon will conduct x-rays to determine the condition of the insert and advise on what further steps may need to be taken. In most cases, surgeons will reach out to patients who have received one of the affected inserts. However, you should not wait for them to do so. If you suspect that you may have one of the affected components, you should contact your physician or surgeon immediately.

Get Legal Help – How Can an Exactech Implant Recall Lawsuit Help Me?

After speaking to your surgeon, you should book a consultation with an Exactech recall lawyer to see if you are eligible to join the ongoing class action against Exactech. The personal injury lawyers at Shamis & Gentile, P.A. can help.

Shamis & Gentile, P.A., provides outstanding legal services in Florida and New York. We distinguish ourselves because of our experience and resources, which we combine to handle any kind of case involving personal injury, personal injury protection, class actions/mass tort, and contract disputes. When you bring your case to Shamis & Gentile, you will always work with a seasoned attorney who has an excellent track record. We are progressive and trusted within the legal community, and we are often called upon to settle cases that other law firms may not be able to handle on their own. Contact us for more information or to book a consultation with an Exactech recall lawyer.

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