If you had surgery to replace a knee, hip, or ankle a recall by Exactech Inc., may affect you. This recall involves the polyethylene inserts used in its hip, ankle, and knee replacement systems. The liner in these implants were improperly stored, leading to oxidation prior to implant. The recall affects certain people who received an Exactech total knee, hip, or ankle replacement from 2004 to 2022.

Exactech, headquarted in Gainesville, FL, issued a recall letter to surgeons in February 2022. The letter advised surgeons that defective packing of the plastic inserts used to cushion the joint in the Exactech knee and ankle replacements caused the plastic components to be subjected to oxidation. Exactech discovered this causes premature wear of the polyethylene components. Additionally, it could cause the devices to fail after they were implanted.

Prior, Exactech issued a letter to surgeons to advise of premature device failure with the Connexion GXL liner used in hip replacements. Surgeons have been warning and will continue to notify patients if their device has been recalled. If you have received a recall letter, please call us at 888-783-8378 to speak to a legal professional.

The Ruth Law Team of personal injury professionals wants you to have the most current and accurate information about the Exactech hip, knee, and ankle replacement devices. This is important so you can obtain the medical care needed to correct harm they caused. We also want you to be aware you may be entitled to compensation. This is particularly important in the event you need to have or have had revision surgery.  The Ruth Law Team is here to fight for you. Our clients do not deserve the pain this defective device has caused for almost two decades.

Which Devices Did Exactech Recall?

Exactech identified the several devices it manufactured and sold from 2004 through 2022 as containing materials that may be defective and could cause them to fail. The following knee, ankle, and hip replacements are recalled:

  • OPTETRAK Partial & Total Knee Replacements:
    • All-polyethylene CR Tibial Components
    • All-polyethylene PS Tibial Components
    • B-Series Ps Tibial Insert
    • CC Tibial Inserts
    • CR Tibial Inserts
    • CR Slope Tibial Inserts
    • PS Tibial Inserts
    • CUSTOM OPTETRAK Angled PS Insert
    • CUSTOM OPTETRAK CC Tibial Insert
    • HI-FLEX® PS Tibial Inserts
    • HI-FLEX® PS Tibial Inserts
    • RBK PS Tibial Components
  • Exactech OPTETRAK Logic Total Knee Replacements:
    • CR Tibial Inserts
    • CR Slope Tibial Inserts
    • CRC Tibial Inserts
    • PS Tibial Inserts
    • PSC Tibial Inserts
    • CC Tibial Inserts
  • Exactech Truliant Logic Total Knee Replacements:
    • CR Tibial Inserts
    • CR Slope Tibial Inserts
    • CRC Tibial Inserts
    • PS Tibial Inserts
    • PSC Tibial Inserts
  • Exactech Vantage Total Ankle Replacement:
    • Fixed-Bearing Liner Component
  • Total Hip Replacement Liner:
    • Exactech Connexion GXL polyethylene liner

If you are unsure which component you have, you may request this information from your surgeon. Specifically, ask for the Product ID Sticker and operative report.

Notice of a Class II recall of the knee and ankle products was issued by Exactech on February 7, 2022. Surgeons, hospitals and health care professionals received the notice. It informed them of early deterioration of the polyethylene components that may require surgical removal of defective devices. A separate letter went out to surgeons in June 2021, indicating the Connexion GXL acetabular liner may fail early.

What prompted a recall?

Exactech claims it discovered (through testing) that polyethylene components used in the total ankle, hip, and knee replacement systems were packaged and stored in “non-conforming” vacuum bags. The purpose of the bags was to limit exposure of the polyethylene or plastic components while in storage to prevent deterioration due to exposure to oxygen.

The company says the vacuum bags were non-conforming because they did not contain a secondary barrier to increase resistance to oxygen. In return, this causes deterioration of the plastic components during storage. As a result, total knee, ankle, and hip manufactured between 2004 and 2022 using plastic components may not have been properly protected during storage. This can cause patients to experience premature wear of the plastic components and an increased risk of bone loss. The Exactech Connexion GXL polyethylene liner was taken off the market in 2019.

The recall notification referred to several clinical issues that could arise from deterioration of the polyethylene, including:

  • Mechanical failure.
  • Loosening of the device.
  • Device fracture.
  • Pain.
  • Bone loss.
  • Swelling of the affected area.

Exactech recalled all of its knee and ankle devices manufactured with polyethylene components using the non-conforming packaging. The Florida-based company also directed surgeons not to use the devices for future surgical procedures.

Recall notification issued by Exactech

The first notification of an issue with premature polyethylene wear was in June 2021 when Exactech issued a recall of the plastic components used in its hip replacement devices. According to the recall notice issued by the company, deterioration of the polyethylene components caused implant failures of its hip replacement devices.

A recall notice issued by Exactech on February 7, 2022, for its total knee and ankle devices referenced early deterioration of the polyethylene components as causing patients to undergo earlier than anticipated revision surgery. This issue was identical to the one that compelled the company to recall its hip replacement devices eight months earlier.

Recall notice went only to surgeons

If you have not received an Exactech knee and ankle replacement recall notice, contact your surgeon. Your knee, hip, or ankle device may be included in the recall. Only surgeons received the February 7, 2022, Class II recall notice from the company. Thus, you likely did not receive a letter directly from Exactech. The Food and Drug Administration’s letter did not directly send a letter to patients with a recalled device.

Instead, the letter instructed surgeons, hospitals and health care providers to discontinue use of the devices for any upcoming surgical procedures. Exactech suggested that the surgeons and other health care professionals use their own version of a sample letter provided by the company to notify patients who received the devices between 2004 and 2022.

The Exactech knee and ankle replacement attorneys of The Ruth Law Team want to make certain that you know about this recall. You have important legal rights. Don’t wait; take immediate action to protect these rights. We can help you to determine if the replacement knee or ankle that you received was one of the recalled devices. Our attorneys can also determine if you may be eligible for compensation for harm it may have caused. Contact us at 888-783-8378 to see if you qualify. We serve clients throughout the state of Florida, however, many of our clients live in other states. Regardless of your location, our attorneys are standing by to help.

What if you received an Exactech knee, ankle or hip replacement?

The notice sent to surgeons recommends against removing an Exactech device absent evidence of its failure as long as it functions properly and is not causing pain or discomfort to a recipient. The company advised physicians company to monitor patients who complain of any of the following symptoms:

  • Knee or ankle instability.
  • Weight-bearing issues.
  • Noises, including grinding sound, emanating from the joint.
  • Swelling or complaints of pain.

Additionally, Exactech advised surgeons to evaluate recipients of the devices for potential wear, osteolysis or bone loss, and other signs of failure. The company also recommends physicians use X-rays to assist in evaluating device failure. This testing can help regardless of the product’s shelf life and regardless of how much time has elapsed since the replacement surgery. If you have a recalled device, don’t delay in seeking legal representation. Time is of the essence. Contact The Ruth Law Team today for a free case evaluation.

What are your legal rights and options?

If you receive a copy of the form letter provided to your surgeon or the hospital where the replacement surgery was performed, you will notice that it refers to a process implemented by Exactech for handling patient claims. The process uses a third-party administrator working on behalf of Exactech to assist patients seeking reimbursement for their out-of-pocket costs related to the recalled devices.

Instead of relying on an administrator chosen by the company that made the defective device to look out for your legal rights, a better approach is to contact a member of The Ruth Law Team. Our team has experience as a nationwide law firm of aggressively pursuing claims against companies, such as Exactech, that produce and sell products that cause harm and injuries. We work for you.

If you believe you have a claim against Exactech, we offer a free consultation and review of your claim. Learn more about how we can help by contacting us today at 888-373-0625.