Exactech, Inc.: recalls, TPG ownership and bankruptcy

analysisA founder-controlled implant maker, a private-equity owner and a packaging defect that spread across four product families: the dossier links Exactech's SEC filings, the FDA's safety communications, recall records and warning letters, the MDL, Florida, Australian and qui tam dockets, the Chapter 11 record and register entries from 1985 to October 2026, and keeps each allegation beside the response and outcome on record. ^{1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32}

analysisExactech, Inc. is a Florida corporation (document H85101) founded in 1985 by the orthopaedic surgeon William Petty, the biomedical engineer Gary J. Miller and Betty Petty, with its operating base at 2320 NW 66th Court, Gainesville. It began with a cemented hip system, developed its first knee implant in 1992, entered the shoulder market in 2005 and in 2014 acquired the computer-assisted surgery business behind ExactechGPS. In 2024 it made about 70% of its products in-house at plants in Gainesville and Sarasota, Florida, and Gieres, France, and employed about 900 people. ^{1 2 3 4 5 6 7 8 9 10 11}

analysisThe Petty family controlled the company before and after its 1996 listing, and William Petty still beneficially owned about 24% when affiliates of the private-equity firm TPG agreed in October 2017 to buy it. After the price was raised to $49.25 a share, the merger closed on 14 February 2018 in a deal valued at about $737 million: Exactech left Nasdaq and became an indirect wholly owned subsidiary of Osteon Holdings, Inc., while the Pettys and other insiders exchanged part of their shares for shares in the new parent. ^{1 2 3 4 5}

analysisFrom June 2021 Exactech recalled polyethylene hip liners, then knee and ankle inserts and, in 2024, shoulder and patella components, most of them made between 2004 and August 2021 and packaged in bags missing an oxygen-barrier layer. The FDA warned patients in a safety communication of March 2023 and sent the company a warning letter in January 2024. By the October 2024 bankruptcy about 2,600 patients had sued, most of them in a federal multidistrict litigation in New York and in a coordinated Florida state case. ^{1 2 3 4}

qualification

This is the company's own description in a sworn bankruptcy declaration; the regulator's characterisation is in its safety communications and recall records.

response

In the same declaration the company said that, placing patients' interests first, it had proactively implemented the voluntary recall although internal and outside materials-science experts had confirmed through industry-standard laboratory testing that the packaging would not affect the clinical performance of most of the recalled components; and that, although it initiated the recalls in an abundance of caution, it has consistently maintained that the non-conforming bags have not led to overall higher rates of revision surgery beyond industry averages (5–10% at ten years of follow-up), a position it believes scientific and clinical data support. It did not answer a national newspaper's questions on the subject in May 2025. Exactech answered the Form 483 observations on 13 October 2023, describing systemic corrective actions: a retrospective review of complaints, revised procedures and staff training, an assessment under CAPA2023-042 of how historical complaints had been coded, and a revision of its medical-device-reporting procedure due by 31 December 2023. The FDA said the adequacy of the response could not yet be determined because the actions were still under way.

outcome

Exactech initiated the shoulder recall in March–April 2024.

analysisIn 2010 Exactech entered a deferred prosecution agreement with federal prosecutors over a charge that it had conspired to induce surgeons to use its products through consulting agreements, and paid $2.99 million in a related civil settlement. In September 2025 it agreed to pay $8 million to resolve whistle-blower and government allegations under the False Claims Act that it had sold knee implants while knowing of their premature failure. ^{1 2 3 4}

qualification

A deferred prosecution agreement is not a conviction: the complaint was to be dismissed if the company complied for 12 months. The civil settlement resolved government claims without a judgment. The Justice Department states that the claims resolved by the settlement are allegations only and that there has been no determination of liability.

response

In the agreement the company undertook to acknowledge responsibility for its behaviour, to continue cooperating with the prosecutors and other agencies and to carry out further remediation; the prosecutors acknowledged that neither the agreement nor the criminal complaint alleged that the company's conduct had adversely affected patient health or patient care.

outcome

The record does not contain the dismissal order; the Settlement Trust's 2026 complaint refers to the agreement as having expired. Settled for $8 million in September 2025; Exactech declined the Corporate Integrity Agreement and remains on the OIG's heightened-scrutiny list.

analysisOn 29 October 2024 Exactech and four affiliates filed for Chapter 11 in Delaware. The plan confirmed on 17 September 2025 sold substantially all of the business to an ownership group of Strategic Value Partners, Stellex Capital Management and Greywolf Capital Management, which launched it as Advita Ortho, LLC in November 2025, and created the Exactech Settlement Trust to pay personal-injury and wrongful-death claims. ^{1 2 3 4 5 6 7 8 9}

qualification

The owners, board and executives are as stated by Advita Ortho itself, except Demski's board seat, which another company's SEC filing also records; the owners' shares are not disclosed.

outcome

The plan was confirmed on 17 September 2025. The notice of the plan's effective date was not retrieved, so the effective date is not stated from the record.

analysisA plan proposed in spring 2025 would have released TPG from liability for $10 million; the debtors withdrew that settlement after creditors objected, and the claims passed to the Settlement Trust. In January 2026 the trust sued seven TPG entities, seven current or former TPG people and advisers, and William and David Petty in the Delaware Court of Chancery, alleging that TPG acted as Exactech's alter ego and that the individuals breached their fiduciary duties. TPG has denied wrongdoing, and the case was pending in October 2026 without a ruling. ^{1 2 3 4 5 6}

qualification

The amounts and the committee's estimate are as reported by the press; the special committee's report was 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

TPG told the national newspaper that it was 'categorically false' to allege that it had 'encouraged or engineered a bankruptcy filing to protect itself from liability'.