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Do You Qualify?
Eligibility Checklist
- Received an Exactech Optetrak, Optetrak Logic, or Truliant knee replacement system
- OR received an Exactech hip system (Alteon, Novation, Connexion) or Vantage ankle system
- Device was implanted approximately 2004–2021 (packaging defect timeframe)
- Experienced symptoms: knee pain, swelling, instability, grinding, reduced range of motion
- Required or been recommended for revision surgery to replace the failed components
- Received notification from surgeon or hospital about the Exactech recall
- Have not yet experienced symptoms but received a recalled device and are monitoring
Injured? Get a free Exactech Knee Recall case review.
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The Exactech recall stems from a manufacturing and quality control failure spanning nearly two decades. From approximately 2004 through 2021, Exactech packaged polyethylene (PE) tibial and patellar liners for its knee systems — Optetrak, Optetrak Logic, and Truliant — in vacuum-sealed bags missing the inner oxygen barrier layer required by industry standards. The same defect affected hip (Alteon, Novation, Connexion) and ankle (Vantage) components. Oxidized PE generates microscopic wear particles upon implantation. These particles trigger a cascade: the immune system attacks the debris, causing osteolysis (bone resorption), which destabilizes the implant and ultimately causes joint failure. Plaintiffs' experts argue Exactech's packaging violated FDA Quality System Regulation (QSR) requirements and that the company's own packaging specifications required the inner barrier — making this a manufacturing defect, not a design compromise. The discovery rule is critically important: many patients whose implants have not yet visibly failed are still pre-symptomatic. These patients qualify for monitoring and early case registration, and may file once failure occurs. Patients who have already undergone revision surgery have the strongest current claims. Exactech's parent, TPG Capital, is targeted under alter-ego and successor liability theories — plaintiffs argue TPG's post-acquisition cost-cutting and failure to remediate the known defect make TPG jointly liable.
Exactech Recall Settlement Value Tiers
No global Exactech settlement has been announced as of February 2026. These estimated ranges are based on comparable orthopedic device recalls (DePuy ASR, Stryker Rejuvenate, Zimmer Durom Cup), early confidential settlements reported by plaintiff attorneys, and the severity of injuries sustained. Individual case values depend on implant type, documented failure, surgical outcomes, and jurisdiction.
Recall Notification — No Revision Surgery Yet
ModerateSettlement Range
Criteria
- Received an Exactech recalled device
- Confirmed by surgeon that implant is subject to recall
- Experiencing monitoring visits and imaging
- No revision surgery performed or currently scheduled
- May have mild symptoms such as increased pain or stiffness
Revision Surgery Recommended or Scheduled
SeriousSettlement Range
Criteria
- Surgeon has recommended revision surgery based on imaging or clinical findings
- Evidence of implant loosening, osteolysis, or PE liner degradation on imaging
- Revision surgery has been scheduled but not yet completed
- Experiencing significant pain, instability, or reduced mobility
- Lost wages or required medical leave in anticipation of surgery
Revision Surgery Completed — Good Recovery
SeriousSettlement Range
Criteria
- Revision surgery completed to replace failed Exactech components
- Documented implant failure attributed to oxidized PE liner
- Reasonable post-operative recovery without major complications
- Experienced significant pain, extended recovery, and medical costs
- Lost wages and reduced quality of life during recovery period
Complex Revision — Complications, Bone Loss, or Infection
CatastrophicSettlement Range
Criteria
- Revision surgery complicated by periprosthetic joint infection (PJI)
- Significant osteolysis requiring bone grafting or augmentation
- Two or more revision surgeries required
- Permanent disability, chronic pain, or inability to return to prior activity level
- Nerve damage, vascular injury, or other serious surgical complication
- Wrongful death resulting from surgical complications
These ranges are estimates based on comparable orthopedic device litigation and are not guarantees of recovery. No settlement fund has been established. Actual compensation depends on individual facts, jurisdiction, and litigation outcomes. Consult a qualified attorney for an evaluation of your specific claim.
Who Is at Risk — Exactech Recall Patient Exposure Profiles
Common Tasks
- Uses exactech knee recall products or devices as described
- Seeks medical evaluation for related symptoms or injuries
- Consults healthcare provider for ongoing care
- Documents exposure history and medical records
Common Tasks
- Uses exactech knee recall products or devices as described
- Seeks medical evaluation for related symptoms or injuries
- Consults healthcare provider for ongoing care
- Documents exposure history and medical records
Common Tasks
- Uses exactech knee recall products or devices as described
- Seeks medical evaluation for related symptoms or injuries
- Consults healthcare provider for ongoing care
- Documents exposure history and medical records
Common Tasks
- Uses exactech knee recall products or devices as described
- Seeks medical evaluation for related symptoms or injuries
- Consults healthcare provider for ongoing care
- Documents exposure history and medical records
Internal Documents & Evidence
Comparable Device Recall Litigation Benchmarks — DePuy, Stryker, Zimmer Settlements
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Impact:
Exactech Expanded Recall — February 2022 (147,000 US Patients)
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Impact:
Exactech Internal Quality Control Documents — Alleged Packaging Defect Knowledge Pre-Acquisition
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Impact:
Academic Studies on Polyethylene Oxidation and In Vivo Implant Failure (ASTM F2345)
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Impact:
Exactech Voluntary Recall Notice — August 2021 (FDA MedWatch)
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Impact:
Injured? Get a free Exactech Knee Recall case review.
Get Your Free Case Reviewor call 1-800-555-0100
FDA Recall Actions and Regulatory History — Exactech Orthopedic Implants
Exactech voluntarily initiated a recall of affected knee, hip, and ankle replacement components in August 2021 after identifying that PE liners had been packaged in non-conforming single-layer bags lacking an inner oxygen barrier. The FDA assigned a Class II recall designation, indicating a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Affected devices included Optetrak, Optetrak Logic, and Truliant knee systems, as well as select hip and ankle components.
Exactech dramatically expanded its recall in February 2022 to include approximately 147,000 affected devices across multiple product lines in the United States, plus additional patients worldwide. The expanded recall encompassed all major Exactech joint replacement lines: Optetrak, Optetrak Logic, and Truliant knee systems; Alteon, Novation, and Connexion hip systems; and the Vantage total ankle replacement system. Exactech issued updated physician and patient letters urging surgeons to identify affected patients and arrange for clinical evaluation and imaging follow-up.
The FDA confirmed its Class II recall classification for the Exactech devices, placing the recall in the agency's enforcement database and MedWatch recall system. Unlike a Class I recall (which indicates a reasonable probability of serious adverse health consequences or death), Class II indicates the lower-tier risk designation — a classification criticized by patient advocates and plaintiffs' attorneys who argue the oxidative degradation risk and revision surgery burden warrant Class I status. The FDA's CDRH division opened a review of Exactech's post-market surveillance obligations.
Following the recall, the FDA's Center for Devices and Radiological Health (CDRH) initiated review of Exactech's 510(k) substantial equivalence clearances for the recalled devices to assess whether the packaging defect constituted a material change that should have triggered a new 510(k) submission. Plaintiffs' attorneys have argued that Exactech's continued use of non-conforming packaging without notifying the FDA or filing a supplemental 510(k) constitutes negligence per se and supports failure-to-warn and fraud theories.
Following its public listing, TPG Capital was required to disclose in SEC filings the financial impact of the Exactech recall, including recall-related costs, legal reserves, and potential litigation exposure. Public filings acknowledged the recall but did not disclose specific settlement reserve amounts. Plaintiffs' attorneys have used these disclosures in litigation to argue that TPG Capital — as the private equity owner with board-level oversight — bears direct liability alongside Exactech for the packaging defect and its consequences.
Significance Legend
Exactech Inc. and TPG Capital — Corporate History and Litigation Exposure
Timeline: Exactech Inc. / TPG Capital
Exactech Inc. was founded in 1988 (incorporated 1985) in Gainesville, Florida by orthopedic surgeons and engineers. The company grew to become a mid-sized orthopedic device manufacturer specializing in knee, hip, and ankle replacement systems, competing against larger players such as DePuy (J&J), Stryker, and Zimmer Biomet.
Exactech launched the Optetrak total knee replacement system in the 1990s. The system, including its PE tibial and patellar liners, became the company's flagship product and was implanted in hundreds of thousands of patients worldwide over the subsequent decades. The Optetrak Logic and Truliant systems followed as next-generation variants.
Court documents and lawsuits allege that Exactech began using non-conforming single-layer vacuum packaging bags for PE liners as early as 2004, omitting the required inner oxygen barrier layer. This defect allegedly continued unaddressed for approximately 17 years. Plaintiffs contend that internal quality control records show awareness of the deviation from packaging specifications during this period.
Private equity firm TPG Capital acquired Exactech Inc. in 2018 in a take-private transaction valued at approximately $737 million. Post-acquisition, Exactech was de-listed from NASDAQ. Lawsuits allege that TPG's cost-cutting imperatives following the leveraged acquisition contributed to delayed corrective action on the packaging defect, prioritizing financial returns over patient safety. TPG's deep financial resources make it a valuable litigation defendant alongside Exactech.
Exactech initiated a voluntary recall in August 2021 after the packaging defect was identified, notifying surgeons and patients that PE liners in affected lot numbers may have been compromised by oxygen exposure. The FDA assigned a Class II recall designation. Initial recall scope was narrower than the February 2022 expansion.
In February 2022, Exactech dramatically expanded the recall to approximately 147,000 patients in the United States across all major product lines: Optetrak, Optetrak Logic, and Truliant knee systems; Alteon, Novation, and Connexion hip systems; and the Vantage total ankle system. Surgeon and patient notification letters urged clinical evaluation and imaging follow-up for all affected patients.
Plaintiffs' attorneys across the country began filing lawsuits against Exactech and TPG Capital in 2022, alleging manufacturing defect, design defect, failure to warn, negligence per se, breach of warranty, and fraud. Case concentration emerged in New York state courts and the Middle District of Florida (Exactech's home district). Over 1,000 cases were filed by Q4 2025 with MDL consolidation discussions ongoing.
As of early 2026, the Exactech litigation remains in pre-trial phases with no bellwether verdicts and no global settlement announced. Expert discovery and science days are anticipated in 2026, with first bellwether trials potentially scheduled for 2027. Some confidential individual settlements have been reported but no public settlement fund or matrix has been established.
Notable Verdicts & Settlements
Johnson & Johnson's DePuy Orthopaedics division settled approximately 8,000 claims in the ASR hip recall MDL for a global fund exceeding $2.5 billion. Average per-claimant settlements were reported at approximately $228,000, though cases with serious complications settled for significantly more. The DePuy ASR recall is the closest comparable to the Exactech recall in terms of defective orthopedic implant causing premature failure and requiring revision surgery. This settlement is frequently cited by plaintiff attorneys as a benchmark for Exactech case values.
Stryker Corporation settled claims arising from the Rejuvenate and ABG II hip stem recalls for over $1 billion, with average per-claimant settlements reported at approximately $300,000+. The Stryker recall, like Exactech's, involved a packaging/materials defect causing premature implant failure and mandatory revision surgery. The higher average per-claim value in Stryker compared to DePuy is frequently cited by plaintiff attorneys as an upward data point for Exactech valuation.
Zimmer Biomet's Durom Cup hip implant recall resulted in individual trial verdicts ranging from $1 million to $5 million for cases with serious complications. Settled cases averaged approximately $100,000–$500,000 depending on injury severity. The Durom Cup litigation demonstrated that juries are willing to award significant damages in orthopedic device cases where manufacturer negligence is well-documented, and that cases with permanent disability or multiple revisions command verdicts in the millions.
Plaintiff attorneys have reported that a small number of individual Exactech cases have reached confidential settlements in 2024–2025, prior to any global resolution. The amounts are not publicly disclosed. These early resolutions suggest Exactech and TPG Capital are willing to resolve the strongest individual cases rather than proceed to trial in those specific matters — a common defense strategy to avoid early unfavorable verdicts that would set high precedent for global settlement negotiations.
Injured? Get a free Exactech Knee Recall case review.
Get Your Free Case Reviewor call 1-800-555-0100
Premature Implant Failure from Polyethylene Oxidation
Medical Definition
Accelerated wear and structural failure of a polyethylene (PE) knee replacement liner caused by pre-implantation oxidation resulting from defective packaging. Exactech's PE tibial and patellar liners were sealed in single-barrier bags lacking the required inner oxygen barrier, allowing oxidative degradation of the polymer chains before surgery. Oxidized PE has significantly reduced tensile strength, fatigue resistance, and wear properties, leading to dramatically accelerated in vivo wear — producing osteolytic PE debris and destabilizing the implant within 3–7 years rather than the expected 15–20 year lifespan.
Symptoms
Knee pain at rest or with activity — often increasing over time
CommonJoint instability or feeling the knee will give way
CommonReduced range of motion compared to post-operative baseline
CommonSwelling or warmth around the knee joint
CommonGrinding, clicking, or crepitus with movement
CommonDifficulty walking, climbing stairs, or rising from seated position
CommonVisible leg misalignment or change in limb length
Less CommonAsymptomatic — device failing on imaging without subjective symptoms
Less CommonRisk Factors
- Implant placed between approximately 2004 and 2021 (defective packaging era)
- Higher body mass index — increases mechanical stress on PE liner
- High activity level — accelerates wear of already-compromised PE
- Longer time since implantation — more cumulative oxidative degradation
- Implant placed in younger patient — longer expected functional lifespan stresses degraded component
- Varus or valgus malalignment — uneven load distribution on liner
Treatment Options
Revision Surgery Complications — Periprosthetic Joint Infection and Bone Loss
Medical Definition
Complications arising from revision total knee arthroplasty (rTKA) performed to address Exactech implant failure. Revision surgery is substantially more complex than primary knee replacement, carrying significantly elevated rates of periprosthetic joint infection (PJI, 2–4x higher than primary TKR), blood loss, nerve injury, vascular injury, and need for further revision. Pre-existing osteolysis from PE debris necessitates bone grafting or augmentation in many cases, further increasing operative complexity and complication risk.
Symptoms
Fever, chills, and systemic malaise — signs of periprosthetic joint infection
SeriousWound drainage, redness, or opening at surgical incision site
SeriousPersistent pain and swelling not resolving with standard post-operative timeline
SeriousKnee stiffness and failure to regain expected range of motion after revision
CommonLimb length discrepancy following revision with bone augmentation
Less CommonNumbness or weakness — peroneal nerve injury during revision
Less CommonRisk Factors
- Prior knee replacement surgery — each revision increases infection risk
- Pre-existing osteolysis requiring extensive bone preparation
- Immunocompromised patient status
- Diabetes, obesity, or vascular disease — impairs wound healing
- Prolonged operative time required by complex revision
- Prior corticosteroid injections at the joint site
Treatment Options
Chronic Knee Pain and Functional Limitation from Osteolysis
Medical Definition
Progressive bone loss and chronic joint pain resulting from the immune response to microscopic polyethylene wear debris generated by a degraded Exactech liner. PE wear particles trigger macrophage activation and osteoclast-mediated bone resorption (osteolysis), creating periprosthetic bone defects that destabilize the implant, cause chronic pain, and substantially impair activities of daily living. Even pre-revision, osteolysis produces significant functional limitation and quality-of-life impairment compensable as damages.
Symptoms
Chronic aching or throbbing knee pain — often worse with weight-bearing
CommonActivity avoidance — inability to walk distances, climb stairs, or participate in recreational activities
CommonSleep disturbance due to nighttime knee pain
CommonDepression and anxiety associated with chronic pain and loss of independence
CommonRadiographically visible periprosthetic lucency (bone loss around implant)
SeriousProgressive loosening of tibial or femoral component on imaging
SeriousRisk Factors
- Higher PE wear volume — accelerated by higher activity level or heavier body weight
- Longer implant duration without detection — more cumulative osteolysis
- Failure to identify recall status — delayed notification prevents early monitoring
- Delayed surgical intervention — allows osteolysis to progress, complicating eventual revision
Treatment Options
Exactech Recall Filing Deadline — Don't Let the Clock Run Out
State-Specific Information
Sources & References
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