Exactech® Knee, Hip, and Ankle Recall Lawsuit

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Have you received a letter from your surgeon informing you of a recall regarding your Exactech® knee, hip, or ankle replacement device? You may be entitled to additional compensation including possible claims to help recover medical costs.

Our Lawyers Are Ready to Assist You. 

Robins Kaplan LLP is investigating the device recall of Exactech polyethylene inserts that were used in knee, hip, and ankle arthoplasty. If you have a knee or ankle polyethylene insert included in this recall, and your surgeon contacts you about follow up, please contact us at 1.800.610.7562 for a free evaluation.

Exactech Total Knee Replacement Device Recall

Exactech Recall Knee Device

In February 2022, Exactech issued an Urgent Medical Device Correction Notice informing surgeons that most of the Exactech knee inserts that were manufactured from 2004 until 2022 contained non-conforming packaging layers on the part of the device that fits between the femoral component and tibial component, and acts as the new cushion or cartilage for the replaced knee joint. Specifically, the packaging layers for the plastic insert allow a large amount of oxygen to diffuse into the insert while it’s being stored and before it is implanted, which can lead to a process called oxidation.

Patients who underwent total ankle replacement surgeries in the following locations, but not limited to these locations, may have been affected:

  • Arkansas
  • Birmingham, Alabama
  • Chicago, Illinois
  • Gainesville, Florida
  • Nashville, Tennessee
  • New York City, New York

Exactech Total Ankle Replacement Device Recall

Exactech Recall Ankle Device

As part of the same February 2022 notice, Exactech recalled its total ankle replacement devices that were manufactured between the years of 2017 and 2022. Similar to the knee recall, the polyethylene (plastic) insert that fit between the tibial component and the talar component as the new cushion or cartilage for the replaced ankle joint contained the same defect that allowed the plastic to become oxidized, which can cause the plastic to wear out prematurely before implantation, or to become damaged after it is implanted into the patient’s body.

Patients who underwent total knee replacement surgeries in the following locations, but not limited to these locations, may have been affected:

  • Arkansas
  • Birmingham, Alabama
  • Chicago, Illinois
  • Gainesville, Florida
  • Nashville, Tennessee
  • New York City, New York

Injuries Potentially Related to the Exactech Knee and Ankle Device Recalls

The defect contained within these Exactech knee, hip, and ankle devices can lead to the following injuries:

  • Premature wear of the device
  • Bone loss
  • Disintegration of bone cells (lysis)
  • Pain
  • Loosening
  • Component fatigue cracking/fracture
  • Necessary corrective revision surgery

Patients Who Were Implanted with an Exactech Recalled Device

In August 2021, Exactech recalled its first product due to these defective plastic inserts. Now Exactech has expanded the recall to include the remaining 55,269 non-conforming Exactech Knee and Ankle Ultra-High Molecular Weight Polyethylene inserts in the field, regardless of shelf life. Exactech estimates that there are approximately a total of 147,732 inserts implanted in the US since 2004 that were produced with non-conforming packaging. The Food and Drug Administration (FDA) classified the recall as a Class II recall, which occurs when consumers may experience severe health consequences of a temporary or medically reversible nature.

As part of the expanded recall, Exactech provided surgeons with a draft letter to their patients who were implanted with Exactech knee and ankle devices packaged in non-conforming bags. It was recommended that surgeons customize this letter and send it to patients implanted with non-conforming devices.

Additionally, Exactech provided patients and physicians with:

  • A list of all the surgeons’ knee and ankle patients who received defective non-conforming bags;
  • Frequently asked questions page available online and
  • A tool on Exactech’s website that allows a patient to enter her/his implant serial number and confirm whether or not that implanted device is non-conforming.

Exactech has also published an online list of affected devices, product codes, descriptions, and serial numbers. Recalled devices include the following Exactech knee and ankle systems:

  • Optetrak: 60,926 implanted units since 2004
  • Optetrak Logic: 60,518 implanted units since 2004
  • Truliant Knee Replacement: 24,727 implanted units since 2004
  • Vantage Ankle Implants: 1,561 implanted since 2004

Connexion GXL Hip Replacement Recall

In addition to the knee and ankle recalls, Exactech also recalled around 90,000 hip replacements with Exactech Connexion GLX Liners in June 2021. The company sent an Urgent Healthcare Professional Communication to surgeons, hospitals, and healthcare professions regarding this recall.

Patients who underwent hip replacement surgeries in the following locations, but not limited to these locations, may have been affected:

  • Arkansas
  • Birmingham, Alabama
  • Chicago, Illinois
  • Gainesville, Florida
  • Nashville, Tennessee
  • New York City, New York

How Robins Kaplan Law Firm Can Help With Your Exactech Claim

Unfortunately, Exactech has not yet directly notified individuals who received the recalled knee, ankle, or hip replacements. Instead, the company is relying on surgeons to inform their patients as to whether they are impacted by the defective medical devices.

Should your surgeon contact you about your device, please contact us to discuss your potential claim against the product manufacture, Exactech. You may be eligible to submit a claim if you or a loved one:

  • Have an Exactech hip, knee, or ankle implant, or
  • Suffered side effects from the Exactech implant, or
  • Received a letter or other communication from your surgeon informing you of the recall

Contact Us First

Contact the attorneys at Robins Kaplan first before contacting the Exactech-Broadspire Helpline. By signing or agreeing to compensation with a manufacturer, you may lose other rights to future claims and compensation. Contact a lawyer first.

If you were not yet contacted by your surgeon, Exactech’s online tool can help to determine whether your device is recalled. You will need to enter the serial number of your device, which can be found in your medical records. Exactech is a large medical device company located in Gainesville, Florida.

Our nationally recognized Mass Tort Attorneys assist clients who are injured by dangerous and defective products, and we are available to evaluate your potential claim against the manufacturers of Exactech.

Contact us for a free and confidential evaluation today. To find out if we can help you with a claim, call 1.800.811.9972 or complete our online contact form above.

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