Exactech Recall: Info for Exactech Knee Recall, Ankle Recall, and Hip Recall Patients

By Austin Kirk
Posted February 22, 2022

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UPDATED 06/10/2024: This page provides historical and informational details about the Exactech knee, ankle, and hip implant recalls that impacted more than 270,000 joint replacements between 2004 and 2022. Our law firm is no longer accepting new cases involving Exactech knee, ankle, or hip implants. The information below is provided for reference only.

UPDATED 8/19/2022: Information about a new Exactech recall involving another 40,000 defective hip replacements has been added to this post.

Following reports of premature wear and early revision surgeries, Exactech issued multiple recalls impacting more than 147,000 knee and ankle implants used in joint replacement procedures across the United States since 2004.

The recalls involved polyethylene plastic inserts packaged in defective vacuum-sealed bags, which may have allowed oxygen to degrade the material before implantation. This oxidation increased the risk of implant failure much earlier than expected.

These announcements followed a 2021 Exactech recall, which involved approximately 90,000 Connexion GXL acetabular liners used in hip replacements since 2008. In August 2022, the Exactech hip recall was expanded to include an additional 40,105 Connexion GXL liners manufactured since 2004 that were also found to be vulnerable to early failure.

Across all affected product lines, the Exactech recalls were linked to vacuum packaging that lacked a critical oxygen barrier layer. The exposure to oxygen during storage or shipping may have compromised the polyethylene components, leading to an increased risk of premature wear, fracture, and the need for revision surgery.

In total, more than 270,000 Exactech implants were impacted by the recalls. Many individuals experienced serious complications, including joint instability, pain, and the need for corrective procedures due to failure of the defective components.

Exactech Recall Lawyers

The lawyers at Saiontz & Kirk, P.A. previously investigated Exactech knee recall lawsuits, Exactech hip recall lawsuits and Exactech ankle recall lawsuits for individuals who experienced problems, including:

• Pain, swelling or difficulty bearing weight
• Loosening or instability in the joint
• Grinding, clicking or other noises from the implant
• Revision surgery or medical treatments resulting from the recalls

Although surgeons and hospitals received letters regarding the Exactech recalls between June 2021 and August 2022, the manufacturer did not make a direct effort to notify patients who received the affected implants. Instead, a template recall letter was provided to surgeons, who were asked to notify their patients.

Unfortunately, many individuals who received a recalled knee, ankle, or hip replacement never received a letter or notification from Exactech or their surgeon.

Why did I receive an Exactech recall letter?

On February 7, 2022, surgeons throughout the United States were provided a draft Exactech recall letter (PDF) that could be sent to patients. While some surgeons may have customized this recall notice, the letter sent by Exactech outlines the problems with certain knee and ankle implants packaged in “non-conforming” bags:

During a recent review of its knee implant manufacturing process, Exactech learned that one of the packaging layers for the plastic insert has been out of specification and may allow oxygen from the air to diffuse into the plastic insert prior to it being implanted in your knee. If a large amount of oxygen diffuses into the plastic insert while it’s being stored and before it is implanted, this can lead to a process called oxidation, which can cause plastic to wear out earlier than expected or to become damaged after it is implanted into the patient’s body.

Each of the recalled Exactech knee, ankle, and hip replacements contained a polyethylene plastic insert, which was packaged in a defective vacuum bag. These “out-of-specification” bags do not contain a secondary barrier layer of ethylene vinyl alcohol (EVOH), which provides critical oxygen resistance for the component.

The Exactech poly recall was issued since the defective bags may allow oxygen to diffuse the plastic insert, resulting in oxidation during storage or prior to the joint replacement surgery, placing patients at risk for:

• Degrading Exactech plastic insert
• Accelerated knee wear debris after implant
• Bone loss, loosening, lysis and pain after a knee replacement
• Component fatigue, cracking or fracture
• Premature knee revision surgery

What happens if I did not receive a recall letter?

Many individuals impacted by the Exactech recalls did not receive a formal notice or letter from their surgeon or the manufacturer. Exactech recall letters were not issued directly by the company or the FDA. Instead, surgeons were asked to notify their affected patients based on internal records.

As a result, some individuals were never informed about the recall—particularly those who changed medical providers, lost contact with their doctor, or were treated by surgeons who retired or did not follow through with patient outreach.

In other cases, individuals may have already undergone revision surgery before learning their implant was part of the recall.

What implants are impacted by the Exactech poly recall?

After initially recalling only a limited number of Exactech knee replacements in August 2021, the manufacturer has now widely expanded the recall to include all Exactech polyethylene inserts shipped with knee and ankle implants in non-conforming bags, regardless of the label or shelf-life of the product.

Knee Implants

Three different generations of knee replacements have used these recalled Exactech poly inserts at various points since 2004, including the Exactech Optetrak, Exactech Optetrak Logic and Exactect Truliant knee systems.

Ankle Replacements

The Exactech polyethylene recall has also impacted certain ankle replacements sold since 2016, including the Exactech Vantage ankle system.

Hip Implants

Finally, while not officially “recalled”, Exactech hip replacements implanted since 2008 may contain a defective polyethylene Connexion GXL acetabular liner, which has also been found to exhibit early signs of failure.

How do I find out if I have a recalled Exactech knee, ankle, or hip replacement?

Many individuals may not know the exact brand of Exactech implant used during their joint replacement surgery or whether a recalled plastic insert was involved. In those cases, medical records or information from an orthopedic surgeon were typically required to confirm the implant type and serial number.

While the Exactech recall did not outline the specific serial numbers for implants that were recalled, a webpage has been provided by the manufacturer where you can input the serial number for your implant and find out if it was recalled.

How serious is the Exactech knee recall?

Recalled Exactech knee implants were associated with a substantially increased risk of early failure, often requiring revision surgery. Clinical registry data revealed statistically significant higher revision rates for Exactech Optetrak components compared to other total knee replacement systems.

International data supported concerns about the long-term performance of these implants:

• Australian Registry shows a greater than 10% knee revision rate with 14 to 20 years follow up (374 revisions among 3,684 Exactech Optetrak knee replacements with the polyethylene component)
• United Kingdom Registry shows significant increased cumulative revision rates for the Exactech Optetrak cruciate retaining femoral component at 3 year, 5 year, 10 year, 13 year and 15 year timepoints
• New Zealand Registry found a 9.5% rate of knee revisions with the Exactech Optetrak (63 revisions among 661 primary knee replacements)

While the United States does not maintain a national joint replacement registry, Exactech estimated that its Optetrak knee implant had a revision rate of 1.015 per 100 component years, compared to 0.48 per 100 component years for other knee systems—more than double the risk.

When isolating cases with symptoms linked specifically to polyethylene wear (such as loosening, lysis, and pain), some combinations of Optetrak components were estimated to have a three- to seven-fold increase in failure rates.

Will I need knee revision surgery if I have a recalled Exactech implant?

Exactech has acknowledged that the recalled implants are prone to fail prematurely, which typically results in the need for knee revision surgery. However, pre-emptive removal of recalled knee implants is not being recommended by the manufacturer if the knee is not painful and functioning well.

Individuals who may be impacted by the Exactech recall should contact their surgeon and schedule an examination if they are experiencing any symptoms of knee replacement problems, including:

• New or worsening pain
• Inability to bear weight or difficulty walking
• Grinding, clicking or other noise from the knee implant
• Swelling
• Instability

Doctors will likely recommend an x-ray to evaluate the Exactech knee replacement and status of the recalled poly insert.

If knee revision surgery is not needed, surgeons are being encouraged to maintain an index of patients and monitor for any future risk of:

• Premature wear
• Osteolysis
• Knee failure

If a recalled Exactech knee implant has failed, doctors will likely consider revision surgery. However, as an alternative to knee revision surgery, some doctors may consider an isolated polyethylene insert exchange, as Exactech is providing new plastic knee and ankle inserts that they now indicate are properly packaged in conforming vacuum bags that will avoid future problems with premature wear and failure.

Should I file an Exactech recall claim with Broadspire?

As part of the recall response, Exactech contracted Broadspire, a third-party settlement administrator, to oversee a claims reimbursement program. This program was designed to cover out-of-pocket expenses related to revision surgeries or other recall-related medical costs.

To submit a claim through Broadspire, impacted individuals were typically required to provide:

• Date of the joint replacement surgery where a recalled Exactech implant was used
• Name of the surgeon who performed the knee replacement, ankle replacement or hip replacement surgery
• Serial number for the implant, which is obtained from your medical records or surgeon

After contacting Broadspire about your Exactech recall claim, you will be assigned a claim number and receive instructions for how to submit expenses you have already incurred for reimbursement.