If you have an Exactech knee implant, check the model and ask your doctor about new pain. A recall alone does not mean you need surgery or will receive money.
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These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.
U.S. Food and Drug Administration · Publisher of the Exactech safety communication
Finding: The agency does not recommend removal of well-functioning Exactech devices when patients have no pain or symptoms. New or worsening symptoms need a discussion with the treating provider.
FDA Exactech joint device safety communication (opens in a new tab) · Mar 23, 2023 · Checked Oct 3, 2026
Nicholas G. Garaufis · U.S. District Court for the Eastern District of New York · Judge issuing the October 2022 practice and procedure order
Finding: The dated order governs transferred and related Exactech MDL cases and distinguishes master-docket papers from individual case filings. It does not decide a patient’s recovery.
Garaufis MDL3044 Practice and Procedure Order1 (opens in a new tab) · Oct 25, 2022 · Checked Oct 3, 2026
Laurie Selber Silverstein · U.S. Bankruptcy Court for the District of Delaware · Judge issuing the May 2025 discovery letter
Finding: The letter requires production of parts of documents about claims seeking to reach other parties through corporate relationships. It concerns access to documents, not a patient payment or liability verdict.
Silverstein Exactech bankruptcy discovery letter (opens in a new tab) · May 20, 2025 · Checked Oct 3, 2026
U.S. Food and Drug Administration · 2023
Read the source: FDA Exactech packaging risk review (opens in a new tab) · Checked Oct 3, 2026
U.S. Food and Drug Administration · 2025
Read the source: FDA AcuMatch XLE specific recall record (opens in a new tab) · Checked Oct 3, 2026
Dated court orders describe procedures and a document dispute. Ask for the latest order that governs your own claim.
Not covered by this case
Ask about the percentage, expense deductions and costs if no money is recovered.
Source: ABA Model Rule1.5 Fees · as of Oct 3, 2026
Covered medical copies may have reasonable copying or mailing charges. Search or retrieval charges are barred under HHS access guidance.
Source: HHS your medical records · as of Oct 3, 2026
Ask your care team to match the model and serial number to the recall.
Source: FDA Exactech joint device safety communication · as of Oct 3, 2026
Gather prior filings and notices; ask which deadline and claim rules apply.
Source: USCourts Chapter11 Bankruptcy Basics · as of Oct 3, 2026
Ask about written fees, expenses and next steps before hiring a firm.
Source: ABA Model Rule1.5 Fees · as of Oct 3, 2026
Start by checking which Exactech device you received and whether it was recalled. Gather records of symptoms, care and any prior legal claim. A recall notice alone does not decide whether a firm can take your case.
FDA’s safety notice names Optetrak, Logic and Truliant knee devices in defective bags. It also discusses ankle and hip recalls, which have their own details. The date a device was made is not always the date it was put in your body. Ask your surgeon or hospital to help match the model and serial number to the right notice.
For a review, make a list of the first surgery, later symptoms, tests and any repair or replacement surgery. Keep letters and prior claim receipts with that list. Mark a date as uncertain if you cannot recall it. Ask which records are needed and what facts must be proved. These are preparation steps, not a rule that every patient must have another surgery to ask a legal question.
Exactech’s website now separates contact routes for older implant claims and newer devices or recall questions. Court orders and claim rules need a separate check. Ask your lawyer which process and notice govern your own file.
A federal court order filed in October 2022 set procedures for the Exactech cases in New York. The cases are known as MDL3044. That means cases were brought together for shared court work; the order also describes individual case files. It is a dated procedure order, not a promise that your case will go to trial or result in a payment.
The Delaware bankruptcy court has also issued orders in Exactech’s case. Judge Laurie Selber Silverstein’s May 2025 letter addressed a dispute over which documents had to be shared. That ruling concerns access to documents, not an award for an implant patient. Ask for the latest order that affects your claim instead of relying on that older letter as a status update.
A recall does not give you an automatic payment. Ask which claim process applies to you and what records it requires. If you have an actual offer, ask about its terms and what fees or expenses affect the amount you keep.
Exactech’s hip FAQ says its patient reimbursement program is permanently closed. It says no more requests under that program will be accepted or processed. That notice is about the company’s program. It does not answer every legal question about a prior lawsuit, a bankruptcy claim or a claim against another party. Ask what it means for your records. The FAQ still sends claim questions to Kroll, but the bankruptcy court ended Kroll’s role as claims agent as of September 2, 2026, and told Kroll to send its claim records to Omni Agent Solutions. Under Exactech’s bankruptcy plan, which took effect on October 31, 2025, injury claims go to the Exactech Settlement Trust.
Keep a copy of any claim you sent and any response you received. Ask whether the filing was accepted, whether more proof is needed and who handles it now. Ask about any actual proposed payment and the rights you would give up to accept it. Do not use a recalled-device list as a payment calculator.
Ask whether the review has a charge before you agree to it. Get the lawyer fee and case expenses in writing. Ask what could be due if the claim does not recover money.
The ABA model rule calls for a signed written contingent fee agreement. It should explain the percentage, how expenses are deducted and costs that may be due even if the case fails. It is a model rule, not a price quote from a firm. Ask which rules apply to the agreement you are being offered.
Covered medical providers may charge a reasonable copying or mailing fee for record copies. HHS says they cannot charge a search or retrieval fee under its access guidance. Ask for the records needed to identify your device and explain your care. A record-copy charge is different from the fee for legal help.
Ask promptly about the time limit for your own claim. Bring surgery dates, symptom dates and any court or bankruptcy notices. Do not assume that a recall date is your filing deadline.
General court guidance says time limits depend on the law and the claim. Bankruptcy claims also have rules for records, notices and filings. A time limit from another case may not apply to yours. Ask a lawyer to check the actual notices and latest orders before you decide what to do.
If you already filed, ask for proof of what was sent and when. Ask whether that filing covers the path that applies now. If you received a denial, request for records or court notice, keep the full document. Do not discard it because the company’s old reimbursement program has closed. Ask what dates and next steps matter for your claim.
Check your implant model and serial number with your surgeon or hospital. Contact your clinician about new or worsening symptoms. Gather recall letters, health records and prior claim papers for a legal review.
The manufacturer’s serial-number tool says it covers pre2025 product recalls. Enter all digits, including zeros, if that tool applies to your device. A result for one recall may not answer a question about a later notice. Ask your care team to compare the exact product with the right recall record.
FDA advises contacting your provider for new or worsening pain, swelling, weakness or noise around the implant, or trouble bearing weight. It does not recommend removing a well-functioning device when there are no symptoms. Discuss your own device and health with the clinician. Do not seek surgery just to strengthen a legal claim.
Ask for copies of relevant surgery, diagnosis, treatment and billing records from your covered provider. HHS describes access rights with exceptions. An unpaid care bill alone is not a reason to deny copies. Ask how a family member or lawyer can request records with the proper authority rather than assuming anyone can get them.
First ask which recall affects the device. Then ask which legal process and deadline apply to your file. Read the written fees and expenses before agreeing to legal help.
Keep your medical and legal questions together in one list, but ask the right person each question. Your clinician can discuss symptoms, tests and treatment choices. A lawyer can check the filings and notices that affect your claim. A manufacturer recall tool can help identify a device, but it cannot replace those individual reviews.
Ask what is known, what records are missing and what the next step would cost. Ask who would represent you if you hire the firm. Keep copies of the records you send and the terms you receive. Do not assume an information request or recall lookup has filed a legal claim for you.
FDA links the missing oxygen barrier in packaging to a risk of early plastic wear and device failure. Its notice also warns about bone loss and a possible need for replacement surgery. Those risks do not mean every recalled device has failed.
The packaging should help keep oxygen away from the plastic part before surgery. FDA explains that oxygen can change the plastic over time, a process called oxidation. That can lead to early wear, cracking or failure. A doctor still needs to assess the patient and the device to decide what is causing symptoms and which care is appropriate.
A separate FDA recall record posted in February 2025 concerns specific AcuMatch XLE hip liner products. It describes another missing barrier layer and gives product details. This is not a trial that enrolled patients or a count of all Exactech implants. Matching the model and lot is more useful than assuming every product from the company is covered by one notice.
FDA’s general recall guidance says an implanted device does not always have to be removed. A recall can call for checking or monitoring a device instead. FDA’s Exactech notice asks clinicians to weigh the risks and benefits of treatment case by case. Use the recall information to discuss care, not to choose surgery without that discussion.
Do I need another knee surgery before asking about legal rights? Ask a lawyer about your own records rather than choosing care to fit a claim. FDA does not advise removal of a well-functioning, symptom-free Exactech device.
Does the bankruptcy mean all questions about my implant claim are over? Ask which claim, party and court order apply to you. General bankruptcy guidance describes different rules and exceptions; it is not a decision on your personal claim.
FDA’s safety communication and recall records explain the device risk and care guidance. The manufacturer pages identify recall tools and its own program notices. Dated court orders describe procedures and document disputes. Fee, record and deadline guidance helps you prepare questions; these sources do not promise an individual result.
Exactech's recalled knee, hip, and ankle implants used polyethylene (PE) liners packaged in single-layer vacuum-sealed bags that lacked the required inner oxygen barrier layer. Industry standards require a triple-layer barrier. This packaging defect — present as early as 2004 — allowed ambient oxygen to permeate the packaging and oxidize the PE liner before implantation. Once inside the body, oxidized liners wear at a dramatically accelerated rate, releasing microscopic debris that triggers bone loss and ultimately causes implant failure years before the expected 15–20 year lifespan.
Exactech packaged its PE liners in single-layer vacuum-sealed bags that lacked an inner oxygen barrier layer. Standard industry practice requires a triple-layer barrier (outer structural layer, middle oxygen barrier, inner contact layer). The missing oxygen barrier allowed ambient oxygen to diffuse through the bag and reach the polyethylene liner over months or years of storage and distribution — oxidizing the material before the patient ever received the implant.
Oxygen exposure causes chain scission and cross-linking reactions within the UHMWPE matrix, creating brittle oxidized zones in the liner. When implanted and subjected to the repetitive loading of walking, climbing stairs, or standing, these degraded zones fracture and shed polyethylene particulate debris at a rate far exceeding normal PE wear. Patients may experience accelerated failure within 3–7 years rather than the expected 15–20 year device lifespan.
Microscopic PE wear particles trigger a chronic macrophage-mediated inflammatory response at the bone-implant interface. Macrophages engulf the particles and release cytokines (including TNF-α and IL-1β) that activate osteoclasts — cells that resorb bone. The result is osteolysis: progressive bone loss around the implant. On X-ray, osteolysis appears as radiolucent zones (dark areas) indicating bone destruction that weakens the structural support of the implant.
As osteolysis erodes the bone surrounding the implant components, the mechanical bond between implant and bone deteriorates. Patients experience pain, instability, clicking, and reduced range of motion. Without intervention, the implant loosens catastrophically. Because no infection is present (aseptic loosening), the only treatment is revision surgery — a far more complex and risky procedure than primary joint replacement, requiring bone grafting to address existing defects and carrying higher rates of infection, nerve injury, and repeat failure.
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.
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.
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.
Your state
Deadlines vary by state and by case. A lawyer can confirm yours.
No. FDA does not recommend removal of a well-functioning Exactech implant when there is no pain or symptoms. Ask your clinician about your own device and care.
Source: FDA Exactech joint device safety communication · as of Oct 7, 2026
It depends. FDA says Exactech has an online database for knee and ankle devices that uses the device serial number to check recall status. Use the applicable notice and ask your care team to check the actual model and serial number; a lookup is not a medical or legal decision.
Source: FDA Exactech joint device safety communication · as of Oct 7, 2026
FDA advises contacting your provider about new or worsening pain, swelling, weakness or noise, or trouble bearing weight. A clinician should assess the cause and care choices for your own device.
Source: FDA Exactech joint device safety communication · as of Oct 7, 2026
No. Discuss surgery with your clinician based on your health and device. FDA does not advise removing well-functioning, symptom-free devices. Ask a lawyer about your records without choosing treatment to fit a claim.
Source: FDA Exactech joint device safety communication · as of Oct 7, 2026
No. Exactech states that its patient reimbursement program has been permanently closed and that no further reimbursement claims will be accepted or processed. That notice does not decide every lawsuit or bankruptcy claim, so ask about your actual file and governing rules.
Source: Exactech recall information · as of Oct 7, 2026
No. The Exactech recall date is not automatically your legal filing deadline. Bring surgery, symptom, recall, and claim dates to a lawyer for an individual check.
Source: Southern District of New York: time limits · as of Oct 7, 2026
Gather model and serial details, recall letters, surgery and care records, and any prior filings. Ask which missing records matter and which deadline applies.
Source: HHS: Your Medical Records · as of Oct 7, 2026
Gather the records that identify the implant model, serial number, surgery dates, symptoms, recall letters, and later treatment. Keep gaps marked as unknown instead of guessing. Ask a lawyer which records matter before sending a full file.
Source: HHS: Your Medical Records · as of Oct 7, 2026
Checked against 9 primary sources by People's Justice editors · Updated
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