Exactech Replacement Recalls

Exactech recalled polyethylene liners in knee and ankle implants manufactured in 2004 or later because non-conforming packaging may cause the liners to degrade and fail early, potentially leading to bone loss and revision surgery. Surgeons implanted 147,732 of these recalled inserts in the United States.

Last Modified: April 1, 2022
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Which Exactech Replacement Units Are Being Recalled?

Exactech began recalling polyethylene liners for some of its knee and ankle implants in August 2021.

In February 2022, the company expanded the recall to include “all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life,” according to Exactech’s recall notification.

In June 2021, Exactech issued a letter to doctors advising them that it was phasing out the polyethylene Exactech GXL Connexion liners used in its Novation, Acumatch and MCS systems hip replacement products. This is not a recall, and the company will transition to its new XLE polyethylene liner which is infused with Vitamin E.

Recalled Knee and Ankle Replacements

Exactech recalled all Optetrak, Truliant and Vantage brand knee and ankle replacement liners manufactured from 2004 to present. The company advised surgeons not to implant nonconforming products and to return conforming and nonconforming devices to Exactech.

Recalled Exactech knee and ankle replacements include:
  • Optetrak All-Polyethylene CR Tibial Components
  • Optetrak All-Polyethylene PS Tibial Components
  • Optetrak CR Tibial Inserts
  • Optetrak CR Slope Tibial Inserts
  • Optetrak PS Tibial Inserts
  • Optetrak Hi-Flex PS Tibial Inserts
  • Optetrak Logic CR Tibial Inserts
  • Optetrak Logic CR Slope Tibial Inserts
  • Optetrak Logic CRC Tibial Inserts
  • Optetrak Logic PS Tibial Inserts
  • Optetrak Logic PSC Tibial Inserts
  • Optetrak Logic CC Tibial Inserts
  • Truliant CR Tibial Inserts
  • Truliant CR Slope Tibial Inserts
  • Truliant CRC Tibial Inserts
  • Truliant PS Tibial Inserts
  • Truliant PSC Tibial Inserts
  • Vantage Fixed-Bearing Liner Component

If you have an Exactech implant and aren’t sure if it’s recalled, you can look up the serial number of your device on Exactech’s website.

GXL Hip Liners Pose Risk for Premature Wear

While there is no Connexion GXL hip replacement recall, Exactech has informed surgeons that under certain conditions patients with hip replacements that use the GXL liner may be at risk for higher wear rates. The company observed that a small percentage of patients (.118%) who have had their implant for 3 to 6 years after initial surgery may have earlier wear on the liners.

Exactech listed factors that may contribute to early GXL liner wear, including larger femoral heads, higher patient activity levels, and devices implanted by using a direct anterior hip surgery approach.

Exactech Connexion GXL liners include:
  • MCS LINERs: MCS +5GXL LINER 5/15 DEG; MCS GXL LINER 5/15 DEG; MCS +5GXL LINER 5/15 DEG; MCS GXL LINER 5/15 DEG; MCS +5GXL LINER 5/15 DEG; MCS GXL LINER 5/15 DEG
  • Novation Liners: Novation GXL Neutral Liner, G00, 22mm ID; Novation GXL Liner, Neutral, 28mm; Novation GXL Neutral Liner, G0, 28mm ID; Novation GXL Liner, Neutral, 32mm; Novation GXL Liner, Neutral, 36mm; Novation GXL Liner, Neutral, 40mm; Novation GXL Liner, G00, 22mm ID; Novation GXL Liner, Lipped Ant, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; Novation GXL Liner, Lipped, 28mm; Novation GXL Liner, Lipped Ant, 32mm; Novation GXL Liner, Lipped, 31mm; Novation GXL Liner, Lipped, 32mm
  • Acumatch Liners: Acumatch GXL 0 Degree Liner, 28mm; Acumatch GXL 0 Degree Liner, 32mm; Acumatch GXL 0 Degree Liner, 36mm; Acumatch GXL 15 Degree Liner, 28mm; Acumatch GXL 15 Degree Liner, 32mm

Exactech maintains that the Connexion GXL liners are safe and perform as expected, but they will be phased out of the U.S. market. Some patients have filed hip replacement lawsuits against Exactech over problems with the GXL liners.

Previously Reported Exactech Replacement Problems

Prior to the current recalls, Exactech has faced problems with its joint 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 revision surgery rates increased as high as seven-fold compared to other devices.

It has also faced a whistleblower lawsuit that say the company knowingly giving faulty knee replacement devices to Medicare, Medicaid, and Department of Veterans Affairs beneficiaries.

Did you suffer serious complications after being implanted with an Exactech knee, ankle or hip device?

Why Are Exactech Replacements Being Recalled?

According to Exactech, most of their knee and ankle replacements manufactured since 2004 came with polyethylene plastic inserts packaged in “out-of-specification” bags that could allow oxygen to reach the inserts. This increased oxygen exposure could cause the liners to severely degrade the liners.

The U.S. Food and Drug Administration classified the recall as a Class II. This means the recalled liners could lead to temporary or reversible health consequences. In a Class II recall, the probability of serious health issues is remote. Potential injuries associated with recalled knee and ankle liners include early failure, bone loss and component fracture that could lead to revision surgery.

Revision surgery is a more complicated surgery than a primary joint replacement and often requires longer surgery times and special implants. Medical device registries in Australia, U.K. and New Zealand have found higher revision rates in Optetrak Knee Systems using the polyethylene liner.

How Do You Know If the Exactech Recall Affects You?

Your surgeon may contact you to schedule a follow up appointment if your implant is on the recall list. But if you are concerned and don’t hear from your doctor, you can contact their office to see if your implant has been recalled.

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

Exactech doesn’t recommend revision surgery for patients whose knee or ankle implants are performing well without symptoms.

Watch for Possible Symptoms

Symptoms associated with polyethylene wear are usually related to bone loss or excessive particle debris being released from the degraded liner. But some people may suffer bone loss, also called osteolysis, without symptoms.

Make sure you contact your doctor to see if you need to monitor your implant for potential future issues even if you don’t have symptoms now.

Symptoms to watch for include:
  • Clicking in your knee, ankle or hip
  • Inability to bear weight
  • Instability
  • Noises such as grinding coming from the implant
  • Pain while walking
  • Swelling in the joint

If you have any of these symptoms, contact your doctor right away. They can discuss treatment options, including potential revision surgery to replace the defective insert or the entire device.

What Should You Do If the Recall Impacts You?

If the Exactech knee and ankle recall impacts you, schedule an appointment with your surgeon if they have not already contacted you. If you have a hip implant with a GXL liner, you may also want to contact your surgeon — especially if you are having symptoms.

Exactech recommends doctors closely monitor knee and ankle patients with recalled inserts for potential osteolysis and excessive wearing. They will use X-rays and other diagnostics to determine excessive wear or bone and tissue damage.

You can discuss the risks and benefits of potential revision surgery with your doctor. But if you aren’t having problems, your doctor may just continue to monitor you because additional surgery isn’t recommended if you are asymptomatic.

Some patients may choose to contact Exactech to be reimbursed for out-of-pocket costs, such as medical bills from doctor visits or potential surgery. Lawyers are currently investigating Exactech claims, and patients may choose to file Exactech replacement lawsuits for compensation for medical bills, lost wages, pain and suffering and other damages.

Please seek the advice of a medical professional before making health care decisions.
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