Case research · Sources checked October 1, 2026
Exactech polyethylene knee, hip and ankle implant products liability MDL
Plaintiffs allege that polyethylene components in Exactech knee, hip and ankle implants were packaged in vacuum bags lacking a secondary ethylene vinyl alcohol oxygen barrier, allowing oxidation of the polyethylene before implantation. The complaints claim oxidized polyethylene degrades, causing inflammatory responses, debris, cracking and loosening that lead to premature revision surgery.
Every line on this page is checked against the court docket and the regulators involved. We do not decide whether you are part of this case or match you with a lawyer. What we do is help you get the medical records that matter, from any provider.
- Status
- Active
- Court
- U.S. District Court for the Eastern District of New York
- Docket
- MDL No. 3044; master docket 1:22-md-03044
- Judge
- Hon. Nicholas G. Garaufis
- Started
- October 7, 2022
- Defendants
- Exactech, Inc., Exactech U.S., Inc.
Where it stands
As of October 1, 2026
The JPML's October 1, 2026 report lists MDL 3044 as pending before Judge Garaufis with 1,838 actions pending (1,847 total). Exactech, Inc. and affiliates filed Chapter 11 in the District of Delaware on October 29, 2024 (Case No. 24-12441, Judge Laurie Selber Silverstein); the claims agent's case site shows a plan confirmation order on September 17, 2025 and a plan effective date of October 31, 2025, with a trustee now appearing in the bankruptcy docket. How the confirmed plan channels or resolves MDL personal-injury claims could not be verified from a court-hosted document and is not stated here.[4]
The complaint
What is alleged, and what is not decided
Plaintiffs allege that polyethylene components in Exactech knee, hip and ankle implants were packaged in vacuum bags lacking a secondary ethylene vinyl alcohol oxygen barrier, allowing oxidation of the polyethylene before implantation. The complaints claim oxidized polyethylene degrades, causing inflammatory responses, debris, cracking and loosening that lead to premature revision surgery. For the Connexion GXL hip liner, plaintiffs allege premature wear. Exactech recalled the affected knee/ankle inserts (initiated Aug. 30, 2021, expanded Feb. 7, 2022) and GXL hip liners (June 2021, expanded 2022). These are allegations; the court has not adjudicated liability.
On the record
What the regulators and the court have said
- 01
FDA recall Z-0019-2022 (Optetrak Comprehensive Knee System polyethylene components): Class 2, initiated by firm Aug. 30, 2021, posted Oct. 4, 2021, status 'Open, Classified'; openFDA records the reason as 'Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer' and a quantity of 242,397 devices for that entry. Related entries cover Optetrak Logic (Z-0021-2022; 109,787 devices), Truliant (Z-0023-2022; 31,201 devices) and Vantage ankle liners (Z-0024-2022; 2,217 devices).[6]
- 02
FDA recall Z-2112-2021 (Connexion GXL acetabular polyethylene liners): Class 2, initiated June 29, 2021; reason 'Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients'; 89,050 units total across the GXL entries.[7]
- 03
FDA Safety Communication (issued Mar. 23, 2023; content current Aug. 5, 2024) says the defective bags were missing an oxygen barrier layer, that affected knee/ankle devices were manufactured 2004–August 2021 and may have been implanted through Feb. 7, 2022, and that FDA does not recommend removal of a well-functioning device without new or worsening symptoms.[5]
- 04
openFDA device/enforcement shows all 43 Exactech enforcement entries initiated June 2021–Dec. 2022 classified Class II. openFDA MAUDE returns reports for Exactech Optetrak/Truliant/Vantage/GXL/Connexion brands categorized Injury 4,940, Malfunction 453, Other 337, Death 3 (data last updated 2026-09-29; unverified reports).[8]
Timeline
How the case has moved
Exactech issues 'Urgent Medical Device Correction' for Connexion GXL acetabular polyethylene liners (FDA recall Z-2112-2021 and related entries; Class 2) citing risk of edge-loading and premature wear.[7]
Exactech initiates recall of Optetrak, Optetrak Logic, Truliant knee inserts and Vantage ankle liners packaged without the oxygen barrier layer (FDA recall Z-0019-2022 et seq., Class 2; expanded Feb. 7, 2022).[6]
JPML centralizes 27 actions (plus 48 potential tag-alongs) in E.D.N.Y. before Judge Garaufis as MDL 3044.[1]
JPML transfers the MSP Recovery third-party-payer class action (N.D. Fla.) into the MDL over objections.[2]
FDA issues Safety Communication 'Risks with Exactech Joint Replacement Devices with Defective Packaging' with recommendations for patients and providers.[5]
JPML denies motion to vacate and transfers Grandis (N.D. Ohio) to the MDL, restating the oxidation allegations for Connexion GXL, Optetrak/Truliant and Vantage devices.[3]
Exactech, Inc. and four affiliates file Chapter 11 petitions in the U.S. Bankruptcy Court for the District of Delaware (Case No. 24-12441, jointly administered; Judge Laurie Selber Silverstein).[9]
Bankruptcy court enters order approving the disclosure statement and confirming the Chapter 11 plan; plan effective date October 31, 2025 per the claims agent's site.[9]
JPML pending-MDL report lists MDL 3044 as pending in E.D.N.Y. with 1,838 actions pending.[4]
If this involves you
The records that matter, and who has them.
Whatever you decide to do next, you will be asked for these. They are yours by law, and most providers have up to 30 days to send them once they have your signed request.
Implant record / implant stickers with device serial number, catalog (item) number and UDI for every component
FDA's recall entries and Exactech's serial-number checker identify recalled polyethylene inserts by item and serial number; the serial number is what confirms whether your insert is on the recall list
Held by: Implanting hospital or surgery center (operating-room implant log); sometimes the patient's implant card
Index (original) joint replacement operative report
Documents the date of implantation, surgeon and exact components placed (knee, hip or ankle; polyethylene insert type)
Held by: Implanting hospital; orthopedic surgeon's practice
Serial radiographs and other imaging (X-ray, CT, MRI) with radiology reports
FDA advises monitoring for wear, device failure or bone loss (osteolysis) by imaging; dated images show progression
Held by: Hospital or imaging center radiology department
Revision surgery operative report and explant documentation
Describes the condition of the polyethylene (wear, cracking, oxidation), loosening and what was replaced
Held by: Hospital where revision was performed
Pathology report on retrieved tissue and retained explanted components
Pathology may document polyethylene debris and inflammatory response; the explanted insert is physical evidence — ask whether it was retained or returned to the manufacturer
Held by: Hospital pathology department / surgical pathology
Orthopedic clinic notes and recall notification letters
Clinic notes document symptom onset (pain, swelling, grinding, instability); letters show when the patient or surgeon was notified of the recall
Held by: Treating orthopedic practice; patient
We send the request, follow up with the provider, and deliver the records to you. We don't take case details here and we never share your records with a law firm unless you tell us to.
Questions people ask
Straight answers, with sources
Is the Exactech implant lawsuit real?
Yes. The JPML created MDL No. 3044 in the Eastern District of New York on October 7, 2022 and assigned it to Judge Nicholas G. Garaufis. The JPML's October 1, 2026 report shows 1,838 actions pending in the MDL.[1]
Which Exactech devices were recalled?
FDA's recall database lists Class 2 recalls of Optetrak, Optetrak Logic and Truliant knee polyethylene inserts and Vantage ankle liners (initiated Aug. 30, 2021; expanded Feb. 7, 2022) because they were packaged in bags lacking an oxygen barrier layer, and of Connexion GXL hip liners (initiated June 29, 2021). FDA's 2023 Safety Communication describes the affected devices as manufactured between 2004 and August 2021.[5]
Does FDA say I need my implant removed?
No. FDA's Safety Communication states it does not recommend removal of a device that is working well and causing no pain or symptoms, and advises patients to contact their provider about new or worsening pain, swelling, inability to bear weight, grinding noises or weakness.[5]
What happened when Exactech filed for bankruptcy?
Exactech, Inc. and affiliates filed Chapter 11 in the District of Delaware on October 29, 2024 (Case No. 24-12441, Judge Laurie Selber Silverstein). The claims agent's case site shows a confirmation order entered September 17, 2025 and an effective date of October 31, 2025. The MDL itself remains listed as pending by the JPML; how individual claims are handled under the confirmed plan should be confirmed with the bankruptcy and MDL dockets.[9]
How do I find out if my knee or ankle insert is on the recall?
The recall is defined by item and serial number. Request your implant record (implant stickers/log) and operative report from the hospital where the surgery was done; FDA's Safety Communication notes Exactech provides an online serial-number checker for knee and ankle devices.[6]
Sources
Where every fact on this page comes from
Primary sources only: court orders, the Judicial Panel on Multidistrict Litigation, federal regulators and state attorneys general. Each entry shows the day we opened it. This is reference material, not legal or medical advice.
- [1]MDL No. 3044 Transfer Order (Document 115, Oct. 7, 2022)
JPML · jpml.uscourts.gov · opened October 12, 2026
Centralizes 27 Exactech actions in E.D.N.Y. before Judge Garaufis; summarizes oxidation/packaging allegations and the 2021–2022 recalls.
- [2]MDL No. 3044 Transfer Order (Feb. 6, 2023)
JPML · jpml.uscourts.gov · opened October 12, 2026
Transfers MSP Recovery third-party-payer action into the MDL.
- [3]MDL No. 3044 Transfer Order (Document 291, June 2, 2023)
JPML · jpml.uscourts.gov · opened October 12, 2026
Transfers Grandis to the MDL; restates allegations for GXL, Optetrak/Truliant and Vantage devices.
- [4]Pending MDL Dockets by Actions Pending (Report Date 10/1/2026)
JPML · jpml.uscourts.gov · opened October 12, 2026
MDL 3044 pending in E.D.N.Y. (Garaufis) with 1,838 actions pending, 1,847 total.
- [5]Risks with Exactech Joint Replacement Devices with Defective Packaging - FDA Safety Communication
FDA · fda.gov · opened October 12, 2026
Issued Mar. 23, 2023; describes the missing oxygen-barrier layer, affected devices (2004–Aug. 2021) and patient/provider recommendations.
- [6]Medical Device Recall Z-0019-2022 (OPTETRAK Comprehensive Knee System)
FDA (accessdata.fda.gov) via openFDA device/recall · accessdata.fda.gov · opened October 12, 2026
Class 2 recall initiated Aug. 30, 2021, posted Oct. 4, 2021, status Open, Classified; expansion Feb. 7, 2022.
- [7]Medical Device Recall Z-2112-2021 (Exactech Connexion GXL liners)
FDA (accessdata.fda.gov) via openFDA device/recall · accessdata.fda.gov · opened October 12, 2026
Class 2 recall initiated June 29, 2021 for risk of edge-loading and premature wear.
- [8]openFDA device/event count for Exactech knee/hip/ankle brands by event type
FDA openFDA · api.fda.gov · opened October 12, 2026
Injury 4,940; Malfunction 453; Other 337; Death 3 (data last updated 2026-09-29).
- [9]Exactech, Inc. – Restructuring Administration Cases (Case No. 24-12441, D. Del.)
Kroll Restructuring Administration (court-appointed claims and noticing agent) · restructuring.ra.kroll.com · opened October 12, 2026
Petition date Oct. 29, 2024; Judge Laurie Selber Silverstein; confirmation order Sept. 17, 2025; effective date Oct. 31, 2025; 2026 omnibus hearings with a trustee appearing.