Exactech Replacement Recalls | Hip, knee and ankle units (2023)

What Exactech replacement units are being recalled?

Exactechbegan removing the polyethylene liners from some of its knee and ankle implants in August 2021.

In February 2022, the company expanded the recall to include "all polyethylene knee and ankle arthroplasty inserts packaged in non-compliant packaging, regardless of label or expiration date," according to Exactech's recall notice. In October 2022, the Multi-District Litigation Judicial Panel on Friday consolidated at least 75 lawsuits against Exactech. The company has withdrawn approximately 200,000 knee, hip and ankle replacements since August 2021.

In June 2021, Exactech sent a letter to physicians that it was phasing out polyethylene.Exactech GXL connection linersused in their Novation, Acumatch and MCS systemship replacement products. This is not a recall, and the company will be transitioning to its new XLE polyethylene liner that is infused with vitamin E.

Recall of knee and ankle replacements

Exactech has recalled all Optetrak, Truliant and Vantage knee and ankle replacement casings manufactured from 2004 to the present. The company advised surgeons not to implant non-compliant products and to return compatible and non-compliant devices to Exactech.

Exactech knee and ankle replacements include:

  • Optetrak All-Polietileno CR Tibial Components
  • Optetrak All-Polietileno PS Tibial Components
  • Optetrak CR Sock Inserts
  • Optetrak CR Slanted Tibial Inserts
  • Optetrak PS Sock Inserts
  • Optetrak Hi-Flex PS Sock Inserts
  • Optetrak Logic CR Tibial Inserts
  • Optetrak Logic CR Slanted Tibial Inserts
  • Optetrak Logic CRC Tibial Inserts
  • Optetrak Logic PS Tibial Inserts
  • Optetrak Logic PSC Tibial Inserts
  • Optetrak Logic CC Tibial Inserts
  • Truliant CR sock inserts
  • Truliant CR Slope Sock Inserts
  • Truliant CRC sock inserts
  • Truliant PS sock inserts
  • Truliant PSC sock inserts
  • Vantage Fixed Bearing Lining Component

If you have an Exactech implant and are not sure if you are being recalled, you can look up your device's serial number atSite Exactech.

GXL hip liners pose a risk of premature wear

As long as there is no GXL connectionhip replacement recallExactech advised surgeons that under certain conditions, hip replacement patients using the GXL liner may be at risk for higher wear rates. The company noted that a small percentage of patients (0.118%) who had their implants in for 3 to 6 years after their initial surgery may experience premature wear of the coatings.

Exactech has listed factors that may contribute to early wear of the GXL liner, including larger femoral heads, higher levels of patient activity, and devices implanted using a direct anterior implant.hip surgerygetting closer.

Exactech Connexion GXL coatings include:

  • Novation Coatings:Neutral Coating Novation GXL, G00, 22mm ID; Novation GXL coating, neutral, 28 mm; Neutral Coating Novation GXL, G0, 28mm ID; Novation GXL coating, neutral, 32 mm; Novation GXL boot, neutral, 36mm; Novation GXL coating, neutral, 40 mm; Novation GXL Coating, G00, 22mm ID; Novation GXL Boot, Lipped Ant, 28mm; Novation GXL Coating, G0, 28mm ID; Novation GXL Boot, Lipped Ant, 28mm; Novation GXL liner, with lip, 28 mm; Novation GXL boot, Lipped Ant, 32mm; Novation GXL lining, with lips, 31 mm; Novation GXL Liner, Rim, 32mm
  • Acumatch Coatings:Coating Acumatch GXL 0 Degrees, 28 mm; Coating Acumatch GXL 0 Grade, 32mm; Coating Acumatch GXL 0 Grade, 36mm; 15-degree, 28mm Acumatch GXL liner; Acumatch GXL 15 degree lining, 32mm

Exactech claims that Connexion GXL coatings are safe and perform as expected, but will be phased out of the US market. Some patients presentedhip replacement lawsuitsagainst Exactech regarding issues with GXL coatings.

(Video) About the Exactech Knee and Ankle Replacement Recall - Here Is What You Need To Know

Previously reported Exactech replacement issues

Prior to the current recalls, Exactech had been experiencing issues with gasket replacements. Since the original Optetrak Knee System was introduced in 1992, it has had higher revision rates compared to other knee replacements. Data from Australia, New Zealand and the United Kingdom reported that revision surgery rates increased by up to seven times compared to other devices.

He also faced a lawsuit from whistleblowers who say the company knowingly provided faulty knee replacement devices to Medicare, Medicaid and Department of Veterans Affairs beneficiaries.

Have you had serious complications after implanting an Exactech device in your knee, ankle, or hip?

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Why are Exactech replacements being withdrawn?

According to Exactech, most knee and ankle replacements manufactured since 2004 came with polyethylene plastic inserts packaged in "out of specification" pouches that allowed oxygen to reach the inserts. This increased exposure to oxygen can cause severe degradation of coatings.

The US Food and Drug Administration has classified the recall as Class II. This means that collected coatings can have temporary or reversible health consequences. In a Class II recall, the chance of serious health problems is remote. Potential injuries associated with knee and ankle relining include early failure, bone loss, and fractured components that may lead to revision surgery.

Revision surgery is more complicated surgery than a primary joint replacement and usually requires longer operating times and special implants. Medical device registries in Australia, UK and New Zealand found higher revision rates for Optetrak knee systems using the polyethylene liner.

How do you know if you have been affected by Exactech's retirement?

Your surgeon may contact you to schedule a follow-up appointment if your implant is on the recall list. But if you're concerned and haven't heard from your doctor, contact the doctor's office to verify that the implant has been removed.

In addition, you can look up the serial number of your knee or ankle implant on the Exactech website. The number must be in your medical records. You may also contact Exactech directly at 1-888-912-0403.

Exactech does not recommend revision surgery for patients whose knee or ankle implants are working well and have no symptoms.

Watch out for possible symptoms

Symptoms associated with polyethylene wear are usually related to bone loss or excessive release of particles from the degraded coating. But some people can experience bone loss, also called osteolysis, without symptoms.

Be sure to contact your doctor to find out if you need to monitor your implant for possible future problems, even if you don't have symptoms now.

(Video) Exactech Knee/Ankle Lawsuits: What’s Happening With the Optetrak Recall? | Attorney Helps Nationwide

Symptoms to look out for include:

  • Click on the knee, ankle or hip
  • inability to bear weight
  • Instability
  • Grinding noises coming from the implant
  • pain when walking
  • joint swelling

If you experience any of these symptoms, contact your doctor immediately. They can discuss treatment options, including possible revision surgery to replace the faulty insert or the entire device.

  • Exactech Replacement Recalls | Hip, knee and ankle units (1)

    Related news

    Exactech recalls knee and ankle replacement parts that may fail prematurely

    Exactech Replacement Recalls | Hip, knee and ankle units (2)

    Michelle Llamas, BCPA February 23, 2022

What should you do if you are affected by the recall?

If you are affected by the Exactech Knee and Ankle recall, make an appointment with your surgeon if you have not already been contacted. If you have a hip implant with a GXL coating, you can also contact your surgeon, especially if you have symptoms.

Exactech recommends that clinicians closely monitor knee and ankle patients with inserts removed for possible osteolysis and overuse. They will use X-rays and other diagnostics to determine excessive wear or bone and tissue damage.

(Video) Exactech Knee Lawsuit

You can discuss the risks and benefits of potential revision surgery with your doctor. But if you don't have any problems, your doctor may continue to monitor you because further surgery is not recommended if you are asymptomatic.

Some patients may choose to contact Exactech for reimbursement of out-of-pocket expenses such as medical bills for doctor visits or possible surgery. Exactech's claims are being investigated by attorneys and patients can choose to file them.Exactech Replacement Processesfor compensation for medical bills, lost wages, pain and suffering, and other damages.

Seek the advice of a medical professional before making decisions about your health care.

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