Exactech Knee Recall Lawsuit | 2026 Latest Updates

Lawsuits over Exactech knee implants allege that oxidized polyethylene inserts wore out early. The cases involve the Optetrak, Optetrak Logic and Truliant knee systems. Plaintiffs allege the damage led to cracking, loosening and revision surgery. The FDA classified the related recalls as Class II, and its records list them as open. The recalls cover Exactech devices made from 2004 to August 2021 in defective bags. The FDA warns that oxidation can make devices wear out or fail faster. Individual injury actions are centralized in MDL No. 3044 in a New York federal court. Exactech, Inc.’s Chapter 11 plan took effect on October 31, 2025.

Latest Exactech Knee Lawsuit Updates

July 1, 2026: MDL Case Count Reported

The Judicial Panel on Multidistrict Litigation report dated July 1, 2026 listed 2,893 actions pending in MDL No. 3044 [1]. Judge Nicholas G. Garaufis oversees the MDL. The report does not say how the cases will end. Individual injury actions over Exactech knee, hip and ankle polyethylene components are centralized in one New York federal court. A count of actions is not a finding on any claim.

October 31, 2025: Chapter 11 Plan Takes Effect

The Effective Date of Exactech’s Chapter 11 plan occurred on October 31, 2025, and the plan was consummated. That is according to Kroll, the claims agent, on its case page for Case No. 24-12441 [2].

September 17, 2025: Bankruptcy Court Confirms the Plan

The Bankruptcy Court entered an order on September 17, 2025. It approved the adequacy of the Disclosure Statement and confirmed Exactech’s plan, per the Kroll case page.

September 16, 2025: $8 Million False Claims Act Notice Posted

HHS OIG posted a notice on Oversight.gov on September 16, 2025 [3]. It says Exactech agrees to pay $8 million to resolve False Claims Act allegations for selling defective knee implant devices. KFF Health News reported that the payment to the government resolves two whistleblower lawsuits. They allege Exactech billed health care programs such as Medicare for knee parts it knew were defective [4]. The company did not admit liability.

October 29, 2024: Exactech Files for Chapter 11

Exactech, Inc. and 4 affiliated debtors each filed a voluntary Chapter 11 petition on October 29, 2024. They filed in the U.S. Bankruptcy Court for the District of Delaware. The cases are jointly administered as Case No. 24-12441 before Judge Laurie Selber Silverstein, per the Kroll case page. That bankruptcy case is separate from the MDL.

April 18, 2024: Exactech Announces Patella Recall

Exactech sent surgeons a letter dated April 18, 2024. It announced a lot-specific voluntary recall of Optetrak patella devices manufactured from 2004 through August 2021 [5]. The letter is Exactech’s own notice. It is not an FDA finding. It covers patella lots, which are separate from the polyethylene tibial inserts in the earlier recalls.

November 21, 2023: Urgent Recall Notices Issued

Exactech issued an urgent medical device recall notice to direct consignees on November 21, 2023. It followed 3 complaints for 4 devices about a loss of vacuum in the inner-most vacuum bag. The FDA posted the Truliant record Z-0585-2024 and record Z-0583-2024 for Optetrak Logic on January 18, 2024, after the notice went out [6].

March 23, 2023: FDA Issues Safety Communication

The FDA issued a safety communication on March 23, 2023 [7]. It reminded patients and providers about Exactech joint replacement devices. They were made between 2004 and August 2021, were packaged in defective bags and were recalled in 2021 and 2022.

December 14, 2022: Truliant Knee Complaint Filed

A patient filed a complaint against Exactech, Inc. and Exactech U.S., Inc. on December 14, 2022, numbered 1:22-cv-07893-NGG-MMH [8]. The complaint alleges that a Truliant Posterior Stabilized Knee System implanted on July 19, 2021 failed and needed revision surgery on August 1, 2022. These are allegations and not court findings.

October 7, 2022: JPML Centralizes Cases as MDL No. 3044

The Panel centralized 27 actions from eleven districts as MDL No. 3044, in its transfer order [9]. The cases are before Judge Nicholas G. Garaufis in the Eastern District of New York. The order centralized the actions for pretrial proceedings and made no finding on who is right. It said centralization offers “substantial opportunity to streamline pretrial proceedings, reduce duplicative discovery and conflicting pretrial obligations.”

February 7, 2022: Exactech Expands the Recall

Exactech expanded its voluntary recall on February 7, 2022. The FDA said in its safety communication that the expansion covered every Optetrak, Logic and Truliant knee replacement and Vantage total ankle replacement in defective bags.

October 4, 2021: FDA Classifies Recalls as Class II

The FDA posted and classified the knee polyethylene insert recalls as Class II on October 4, 2021, the agency said in its safety communication. Record Z-0021-2022 covers the Optetrak Logic tibial inserts [10]. A recall classification does not by itself establish liability for any injury.

August 30, 2021: Exactech Initiates Insert Recall

Exactech initiated the recall of knee polyethylene inserts on August 30, 2021, according to the FDA record. Record Z-0021-2022 says the inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. The FDA says the defective bags were missing one of the oxygen barrier layers that protect devices from oxidation, a chemical reaction with oxygen.

January 9, 2018: Pennsylvania Product Liability Lawsuit Filed

A patient filed a product liability lawsuit against Exactech, Inc. and Exactech US, Inc. on January 9, 2018 [11]. It was filed in the Western District of Pennsylvania, No. 2:18-cv-00046. The docket record confirms the filing date, the court, the parties and a product liability cause under federal diversity jurisdiction.

October 11, 2017: Alabama Product Liability Complaint Filed

A product liability complaint against Exactech was filed in the Northern District of Alabama on October 11, 2017, No. 2:17-cv-01735 [12]. The docket shows the complaint as its first entry, against Exactech Inc and Exactech US Inc, with a diversity product liability cause.

What Is Knee Replacement Surgery?

According to MedlinePlus from the National Library of Medicine, knee joint replacement is a surgery to replace a knee joint with a man-made artificial joint. The artificial joint is called a prosthesis [13]. MedlinePlus adds that most artificial knees have both metal and plastic parts. The Exactech recalls involve polyethylene tibial inserts and patellas.

Who May Be Affected?

The devices at issue are Exactech knee replacements dating from 2004 through August 2021 with polyethylene inserts packaged in defective bags. The FDA says the recall covers all Optetrak, Logic and Truliant knee replacements. That holds regardless of a device’s label or shelf life. The FDA tells patients with an implanted Exactech device to contact a health care provider. It lists new or worsening pain or swelling, inability to bear weight, grinding or other noise, or weakness around the implant. Plaintiffs in the MDL describe Optetrak and Truliant knees that failed early and were removed or were due for removal. Only an individual legal review can say whether a specific person’s claim fits.

Reported Injuries or Damages

Plaintiffs allege that oxidized polyethylene in Exactech knee implants causes inflammatory responses, debris, cracking and loosening. Plaintiffs allege these problems require revision surgery. One Truliant complaint alleges pain, swelling, instability, osteolysis and bone loss. These are complaint allegations and not findings. See the page on knee replacement revision surgery for more on that procedure. The FDA says oxidation can lead to accelerated device wear or failure, and component cracking or fracture, all leading to corrective revision surgery. It also says some recalled devices are associated with increased risk of revision surgeries and bone loss related to excessive device wear or failure. Nickel and colleagues reported in 2025 on retrieved Exactech Optetrak inserts. They concluded that non-conforming bags apparently increased the risk of premature oxidation, delamination and associated osteolysis [14].

Recall and Regulatory Background

The FDA lists Exactech’s Class II knee insert recalls as Open. Record Z-0022-2022 covers custom Optetrak inserts, and record Z-0023-2022 covers Truliant tibial inserts [15]. Adding the product-line units on Exactech’s recall page gives 489,498 knee polyethylene components. They were sold worldwide from 2004 to February 22, 2022 in the affected product lines [16]. That count is units sold and not defective units. The FDA says around 80% of the knee and ankle devices made since 2004 were packaged in defective bags. Vantage ankle liners share the recall, as covered on the Exactech ankle lawsuit page.

Evidence to Preserve

These records identify the implant and its history:

• The manufacturer, model and device serial number of the knee implant, since Exactech’s recall check needs the serial number
• Any Exactech or surgeon recall letter you received, including the Exactech Knee Patient Letter
• Operative and hospital records for the knee replacement and any revision surgery
• X-rays and imaging reports
• Medical bills and insurance records
• Dated notes on symptoms such as pain, swelling or grinding

Filing Deadlines

Filing deadlines come from state law. They depend on where you live and on when the injury, the revision surgery and your awareness of a possible cause happened. A missed deadline can end a claim even when the facts are strong, so a lawyer should be asked promptly. Kroll lists deadlines the Bankruptcy Court set for proofs of claim in Exactech’s case. They are February 7, 2025 (General Claims Bar Date), April 28, 2025 (Governmental Bar Date) and August 25, 2025 (DOJ and state False Claims Act claims).

Frequently Asked Questions

Is There an Exactech Class Action Lawsuit?

An Exactech class action lawsuit is not described in the MDL order or docket. The order transferred actions listed on Schedule A for coordinated or consolidated proceedings. The docket lists the nature of suit as personal injury product liability.

How Do I Know If I Have a Recalled Exactech Implant?

To know if you have a recalled Exactech implant, search Exactech’s online database for knee and ankle devices. The FDA says the database shows whether an implant is part of the recall.

What Should Patients with Recalled Exactech Implants Do?

Patients with recalled Exactech implants who have no pain or symptoms are told by the FDA that it does not recommend surgery. That covers removing well-functioning devices. Exactech’s patella notice likewise says revision of well-functioning devices is not recommended.

What Does the Research Say About Exactech Knee Implant Failure?

Research on Exactech knee implant failure includes a retrieval study at one institution. Of 519 Optetrak posterior-stabilized inserts retrieved between 2000 and 2019, 64 (12%) had delamination. Surgical factors and packaging and sterilization dates did not explain it. The authors concluded non-conforming bags apparently increased oxidation risk.

Is a Court Hearing Scheduled in the Exactech Bankruptcy?

A court hearing in the Exactech bankruptcy is listed on the Kroll case page. The page lists a rescheduled omnibus hearing before the Bankruptcy Court on October 2, 2026 and an omnibus hearing on October 13, 2026. It is a scheduling fact and does not predict any result.

How Many Devices Did the FDA Record in the Exactech Knee Recalls?

The FDA recorded devices in the Exactech knee recalls as quantity in commerce for three records. Z-0021-2022 lists 109,787 devices for Optetrak Logic tibial inserts. Z-0022-2022 lists 41 devices for custom Optetrak inserts. Z-0023-2022 lists 31,201 devices for Truliant tibial inserts.

References

1. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-July-1-2026.pdf
2. https://restructuring.ra.kroll.com/exactech/
3. https://www.oversight.gov/exactech-agrees-pay-8-million-resolve-false-claims-act-allegations-selling-defective-knee-implant
4. https://kffhealthnews.org/news/article/exactech-knee-replacement-lawsuits-8-million-dollars-settlement/
5. https://www.exac.com/wp-content/uploads/2024/04/Surgeon-Letter_Voluntary-Recall-of-Exactech-Patella-Devices.pdf
6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=204598
7. https://www.fda.gov/medical-devices/safety-communications/risks-exactech-joint-replacement-devices-defective-packaging-fda-safety-communication
8. https://www.schmidtandclark.com/wp-content/uploads/2022-12-14-Complaint.pdf
9. https://jpml.uscourts.gov/sites/jpml/files/MDL-3044-Initial-Transfer-Order-9-22.pdf
10. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=189260
11. https://www.courtlistener.com/docket/6523321/stanesic-v-exactech-inc/
12. https://www.courtlistener.com/docket/6181984/talley-v-exactech-inc/
13. https://medlineplus.gov/ency/article/002974.htm
14. https://pubmed.ncbi.nlm.nih.gov/40273225/
15. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=189263
16. https://www.exac.com/recall-information/