--- title: "The Settlement Trust's allegations about the recalls" language: en canonical: https://dossiertwist.com/dossiers/exactech/trust-allegations-on-recalls/ as_of: 2026-10-16 keywords: ["Exactech, Inc.","Exactech","TPG","Osteon Holdings, Inc.","William Petty","Jeffrey Binder","polyethylene recall","Connexion GXL","Optetrak","Equinoxe shoulder","MDL No. 3044","Case No. 24-12441","Chapter 11","Exactech Settlement Trust","C.A. No. 2026-0129-MTZ","False Claims Act","deferred prosecution agreement","Advita Ortho","Strategic Value Partners","Exactech U.S., Inc."] --- # The Settlement Trust's allegations about the recalls **Question.** What does the Settlement Trust allege about the recalls, and how have TPG and others answered? **Answer.** The trust alleges that the bags came from Hillman Supply Company, a local supplier that outsourced them and was never audited, that FDA inspections from 2017 to 2023 found repeated failures, and that TPG and Jeffrey Binder took charge of the recall response in 2021 and staged partial recalls. TPG says the packaging problem predated its ownership and that it learned of it in 2021, Binder says the company reported it promptly, and Hillman answered the Florida suits with affirmative defences; no court has ruled on the allegations. ## The packaging supplier - Analysis: The complaint names the supplier of the vacuum bags from 2004 to 2021 as Hillman Supply Company, Inc., a local firm near Exactech's headquarters that it says specialised in janitorial supplies, had the bags made by others and supplied more than 1.4 million of them, almost none with the required EVOH barrier layer, without ever being audited by Exactech. The Florida register lists Hillman Supply Company, Inc. as an active company in Alachua, incorporated in 1993. [s-d24] [s-d218] [s-d198] [s-d217] - Qualification: These are allegations in the Settlement Trust's complaint, which was pending in the Delaware Court of Chancery in October 2026; no court has ruled on them. Hillman is not a defendant in the trust's suit; the FDA's own records and the company's declaration refer only to an unnamed vendor. The match with the supplier named in the lawsuits rests on the name and location; the register does not describe its business. - Response: In the Florida product-liability cases where it was named as a co-defendant, Hillman Supply Company filed an answer with affirmative defences and a jury demand on 26 December 2023. ## Inspections - Analysis: Quoting FDA inspection records that are not public, the complaint alleges that inspections in 2017, 2020, 2021 and 2023 found inadequate complaint investigations, unvalidated packaging and no acceptance checks on the bags, and that the company had extended the stated shelf life of knee inserts around 2007 without reporting it; it counts 20 FDA citations from 2017 to 2023, 13 of them after TPG's acquisition. [s-d24] - Qualification: These are allegations in the Settlement Trust's complaint, which was pending in the Delaware Court of Chancery in October 2026; no court has ruled on them. The FDA inspection forms and reports (Forms 483 and establishment inspection reports) are not published by the FDA and were not retrieved; the findings are as quoted in the complaint. The FDA's 2024 warning letter separately documents the September 2023 inspection. ## Partial recalls and TPG's role - Analysis: The complaint alleges that by July 2021 Exactech's quality chief, Michael Crader, warned that 20 years of supplier certificates had not confirmed the oxygen barrier; that from August 2021 Binder and John Schilling, helped by other TPG staff, took charge of the recall response; and that TPG chose a series of partial recalls, notified distributors before surgeons and widened the recalls only after the FDA intervened, so as to keep revenue stable for a planned listing. [s-d24] [s-d301] - Qualification: These are allegations in the Settlement Trust's complaint, which was pending in the Delaware Court of Chancery in October 2026; no court has ruled on them. The FDA's own records of these recalls are summarised separately; the internal e-mails are quoted from the complaint and were not retrieved. These are allegations in the Settlement Trust's complaint, which was pending in the Delaware Court of Chancery in October 2026; no court has ruled on them. - Response: Binder told a national newspaper in May 2025 that Exactech's investigation of product complaints led it to discover in 2021 a packaging non-conformity that had gone undetected since 2008, many years before TPG's ownership and his tenure, and that when it was discovered Exactech reported it to the FDA in a timely fashion and initiated a recall. TPG told the same newspaper that the packaging issues predated its ownership, that it learned of them only in 2021 and that it 'supported the company as it immediately launched an investigation, initiated a voluntary recall, and provided support programs for physicians and patients'. ## Warnings from surgeons and a second defect - Analysis: The complaint alleges that the Hospital for Special Surgery, Exactech's largest domestic customer, reported a worn and oxidised hip insert in 2017, that in 2018 Binder and William Petty tried to have it withdraw a conference presentation on delaminated components, and that it removed Exactech knees in 2019 and the Equinoxe shoulder in 2021. Citing the creditors' committee, it also alleges that femoral knee components were made to a wrong surface-roughness specification from 2004 to 2021 without a recall. [s-d24] - Qualification: These are allegations in the Settlement Trust's complaint, which was pending in the Delaware Court of Chancery in October 2026; no court has ruled on them. HSS is not a party to the trust's suit; it appears as an interested party in the bankruptcy. These are allegations in the Settlement Trust's complaint, which was pending in the Delaware Court of Chancery in October 2026; no court has ruled on them. The internal evaluation and memorandum are quoted from the complaint and were not retrieved; no recall record for the roughness issue appears in the FDA data reviewed. ## Scale - Analysis: By the complaint's count the seven polyethylene recall events covered nearly 800,000 units worldwide and more than 500,000 implants across the Equinoxe shoulder, several hip lines, the Optetrak, Optetrak Logic and Truliant knees and the Vantage ankle. [s-d24] - Qualification: These totals are the Settlement Trust's compilation from FDA recall data and company statements; they differ in scope from the per-entry quantities in the FDA enforcement reports. ## Sources - [s-d24] Court record source · s-d24 - [s-d218] Court record source · s-d218 - [s-d198] Florida register name search: Hillman Supply, Florida Department of State, Division of Corporations, 2026-10-16 - [s-d217] Florida corporation record: Hillman Supply Company, Inc. (P93000005334), Florida Department of State, Division of Corporations, 2026-01-16 - [s-d301] Media source · s-d301