If you received a recalled Exactech knee, hip, or ankle implant and later needed revision surgery, here is who may qualify in MDL 3044 — and why Exactech's 2024 bankruptcy, rather than a settlement, now controls how injury claims get paid.
Allegations Only · No Settlement Yet
This page describes an investigation and ongoing litigation. The statements below are unproven allegations. Exactech has not been found liable, there is no certified class, and there is no settlement compensating injured patients at this time. This page is informational and is not legal or medical advice. Do not stop using or alter any prescribed treatment without consulting your doctor.
What Is This About?
Did you receive an Exactech knee, hip, or ankle replacement — such as an Optetrak, Optetrak Logic, or Truliant knee, or a Vantage total ankle — and later experience pain, swelling, instability, or an implant that loosened or failed and had to be revised? If so, you may be eligible to speak with counsel about your legal options.Thousands of patients have brought lawsuits alleging that Exactech's orthopedic implants failed prematurely because the polyethylene (plastic) components were sealed in defective packaging that let the plastic degrade before it was ever implanted. The federal cases are consolidated in multidistrict litigation known as MDL 3044, In re: Exactech Polyethylene Orthopedic Products Liability Litigation, before Judge Nicholas G. Garaufis in the U.S. District Court for the Eastern District of New York.
The claims are allegations that have not been proven in court. Importantly, the litigation was reshaped in late 2024 when Exactech filed for Chapter 11 bankruptcy — an automatic stay froze the MDL's bellwether trials, and any recovery for injured patients now depends on the bankruptcy process rather than a jury verdict or a traditional settlement.
The Exactech Recalls
The litigation grows out of a series of recalls that Exactech issued in 2021 and 2022 for the polyethylene inserts used in its joint replacement systems. The company told the FDA the inserts had been sealed in "out-of-specification" vacuum bags that were missing a secondary oxygen-barrier layer.• Knee & ankle inserts: beginning in August 2021 and expanding on February 7, 2022, Exactech recalled the polyethylene inserts for its Optetrak, Optetrak Logic, and Truliant knee systems and its Vantage total ankle system — ultimately covering the affected devices regardless of the label or listed shelf life. A further correction followed in April 2022. Exactech has stated that roughly 80% of the knee and ankle polyethylene inserts manufactured since 2004 were in the defective packaging.
• Hip liners: in a separate, earlier action on June 28, 2021, Exactech recalled its Connexion GXL acetabular (hip socket) liners used in the Novation, Acumatch, and MCS hip systems, citing a risk of accelerated wear.
Plaintiffs allege that once oxygen reached the plastic, it oxidized and became brittle, causing it to wear out, crack, or shed debris far sooner than a properly packaged implant would. The recall agency was the U.S. Food and Drug Administration, which issued a public safety communication describing the packaging problem and the risk of early device failure.
What Do the Lawsuits Allege?
The core allegation is that the defective packaging caused the polyethylene to degrade, producing premature implant failure. Plaintiffs generally raise:• Design and manufacturing defect: that the packaging and the resulting oxidized plastic were unreasonably dangerous.
• Failure to warn: that Exactech did not adequately warn patients and surgeons of the packaging problem, and that the company allegedly should have caught and disclosed it sooner.
The alleged injuries include accelerated polyethylene wear, component cracking or fracture, loosening of the implant, osteolysis (bone loss around the device), synovitis and swelling, pain and instability, difficulty walking, and — most significantly — the need for revision surgery to remove and replace the failed device. None of these allegations has been established as fact against Exactech, and no case has been tried to a verdict.
Who May Qualify?
You may qualify to speak with counsel if you were implanted with a recalled Exactech device and later experienced a documented complication such as:• Revision or removal surgery on the implant
• Accelerated wear, loosening, or component fracture confirmed on imaging or at surgery
• Osteolysis or bone loss around the device
• Chronic pain, swelling, or instability in the joint
Eligibility depends on the specific device, your diagnosis, and the facts of your case. Helpful evidence includes your operative report, the implant identification card or sticker, hospital and billing records, imaging, and records of any revision surgery. Because the claims path now runs through the bankruptcy, deadlines can differ from an ordinary lawsuit — anyone considering a claim should consult an attorney promptly.
Bankruptcy, the Stay & the TPG Lawsuit
The most important development in this litigation is not a bellwether trial — it is a bankruptcy. On October 29, 2024, Exactech and several affiliates filed for Chapter 11 in the U.S. Bankruptcy Court for the District of Delaware. The filing triggered an automatic stay under the Bankruptcy Code, which halted the MDL's scheduled bellwether trials against the company.A reorganization plan was later approved that sold Exactech's operating business and established a litigation and settlement trust to preserve and pursue claims on behalf of injured patients and other creditors. In February 2026, that trust filed a roughly $1 billion lawsuit in Delaware Chancery Court against TPG, the private-equity firm that owned Exactech, and a number of its principals. The trust alleges that TPG controlled Exactech, was aware of the implant problems, and used corporate structuring to try to shield itself from liability. TPG has not been found liable, and those allegations remain unproven.
For injured patients, the practical takeaway is that compensation — if any — is expected to flow through the bankruptcy trust and its recoveries rather than through individual MDL jury verdicts or a conventional class settlement. As of now there is no global settlement, no approved patient-compensation fund amount, and no public claim form to complete on this page. (A separate $8 million federal False Claims Act settlement that has been reported involving Exactech is a government matter and does not pay injured patients.)
Frequently Asked Questions
Which Exactech implants were recalled?
Exactech recalled polyethylene inserts used in its Optetrak, Optetrak Logic, and Truliant knee replacement systems and its Vantage total ankle system, along with Connexion GXL acetabular liners used in its Novation, Acumatch, and MCS hip systems. The company has said roughly 80% of the knee and ankle polyethylene inserts made since 2004 were sealed in the defective packaging.
What was wrong with the recalled Exactech devices?
According to Exactech and an FDA safety communication, the polyethylene inserts were packaged in bags that were missing a secondary oxygen-barrier (vacuum) layer. Plaintiffs allege this allowed the plastic to oxidize before implantation, which they say accelerated wear and led to premature device failure, bone loss, and the need for revision surgery. These are allegations that have not been proven in court.
Is there an Exactech settlement?
No. There is no global settlement compensating injured patients and no bellwether trial has reached a verdict. Exactech filed for Chapter 11 bankruptcy in October 2024, which triggered an automatic stay that halted the MDL trials. Injury claims are now being handled through the bankruptcy process and a litigation trust, and there is no public claim form on this page.
Who may qualify for an Exactech implant claim?
Patients implanted with a recalled Exactech device — an Optetrak, Optetrak Logic, or Truliant knee; a Vantage total ankle; or a Connexion GXL hip liner — who have needed, or may need, revision surgery or who experienced complications such as pain, swelling, instability, or bone loss. Eligibility depends on the device, the diagnosis, and the facts of each case.
Related Mass Torts & Sources
• Bard & Davol hernia mesh lawsuit (MDL 2846) — another large medical-device product-liability MDL.• Bair Hugger surgical warming device lawsuit (MDL 2666) — alleged deep-joint infection after hip and knee replacement.
• Philips Respironics CPAP / BiPAP recall settlement — a recalled-device economic-loss settlement.
Primary sources: U.S. Judicial Panel on Multidistrict Litigation (JPML) pending-MDL statistics; the FDA safety communication on Exactech joint replacement devices with defective packaging; the U.S. District Court for the Eastern District of New York MDL 3044 docket; and reporting by Bloomberg Law and Law360 on the Chapter 11 bankruptcy and the trust's lawsuit against TPG.
Important Disclosures
This page is for general informational purposes and does not constitute medical or legal advice. You should consult a qualified attorney about your individual situation. OpenClassActions.com is not a law firm and is not a claims administrator, and this page does not create an attorney-client relationship.Free settlement alerts
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