What was the Defect in Exactech Packaging?

Joint replacement devices were packaged in defective bags that lacked one of the oxygen barrier layers necessary to protect the components from oxidation—a chemical reaction with oxygen that can cause plastics to degrade. Oxidation can lead to cracking or fracturing of critical parts of a device, with accelerated wear and device failure. The failure of the Exactech device may result in bone loss and the need to undergo revision surgery. The FDA recommends contacting your doctor if you have an Exactech joint replacement device and experience worsening pain, inability to bear weight, swelling, or other symptoms. 

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Which Exactech Devices Have Been Recalled?

The FDA issued a Safety Communication regarding the risks associated with Exactech knee, ankle, and hip replacement devices with defective packaging on March 23, 2023. It issued another Safety Communication on April 19, 2024, regarding the risks associated with the Exactech Equinoxe Shoulder System. The agency instructed healthcare providers not to implant any devices recalled by Exactech. These include devices manufactured between 2004 and August 2021 and recalled in 2021, 2022, and 2024. Many Exactech devices were packaged in defective bags. Recalled Exactech joint replacement devices include:

  • Hip: Models Novation, AcuMatch, andMCS, initial recall June 2021
  • Knee: Models Optetrak Logic, Truliant, and Arthrofocus, initial recall August 2021
  • Ankle: Model Vantage, initial recall August 2021
  • Shoulder: Model Equinoxe Shoulder System, initial recall March 2024

What Are the Complications of a Defective Exactech Joint Replacement Device?

Joint replacement with a defective Exactech device can lead to various complications, including:

  • Persistent or worsening pain in the joint
  • Unusual or prolonged swelling in the area
  • Reduced range of motion and limited joint mobility
  • Sensation of joint instability or looseness
  • Grinding or clicking sensations or unusual noises from the joint
  • Infection or inflammation of the area
  • Excess fluid accumulation around the joint
  • Recurrent dislocations of hip replacements
  • Loosening of implant components
  • Bone loss around the implant
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What are Your Options if You Have a Defective Exactech Joint Replacement?

See your orthopedic surgeon as soon as possible if you are experiencing symptoms related to problems with a hip, knee, ankle, or shoulder replacement. Find out from your medical records if you were implanted with a recalled Exactech device. If you were, depending on the circumstances, your doctor may recommend imaging studies and potentially revision surgery. Once you have the relevant information, speak with an Exactech product liability lawyer about your legal options. You may be entitled to bring a legal action to recover compensation for your past and future medical expenses, lost wages, pain and suffering, and other damages. 

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Why Choose McMath Woods as Your Exactech Lawyers?

McMath Woods is a premium law firm with a 70-year history. We have two Arkansas locations, in Little Rock and Fayetteville. Our legal team consists of actual trial lawyers, and we get most of our cases from referrals. Since 1953, we have been focused on exceptional service and outstanding legal results. We take pride in every case we represent and invest the time and resources necessary to move our cases through the legal process. Call us for a free consultation if you or your loved one has been implanted with a defective Exactech joint replacement device. 

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