FDA inspections and warning letters

analysisFDA's Center for Devices and Radiological Health sent Exactech warning letter CMS #669904, dated January 19, 2024 and addressed to president and chief executive Darin B. Johnson, after inspecting the Gainesville facility from September 18 to 26, 2023. It found the Equinoxe aTSA and rTSA devices and other implants adulterated because their manufacture did not conform to the Quality System regulation, noting that Exactech had not identified the actions needed to correct polyethylene shoulder implants in bags that did not meet material or oxygen-transmission specifications and that its health hazard evaluation had not considered all complaint data. It also found the implants misbranded under the medical device reporting rules, citing a GXL hip-liner failure linked to the packaging that led to revision surgery and was not reported within 30 days. FDA wrote that it could not yet determine the adequacy of Exactech's October 2023 response; in April 2024 it reported that Exactech had begun recalling unused Equinoxe shoulder devices in defective bags, and no close-out of the letter is in the retained record. ^{1 2}

analysisFDA sent warning letter CMS #720250, dated December 19, 2025, to Aurelio Sahagun as president and chief executive of "Exactech, Inc. dba Advita Ortho" in Gainesville, after inspecting the Sarasota facility from July 15 to 25, 2025, with findings on the Equinoxe Reverse Shoulder Compression Screw and other devices. The letter states that the sole supplier of a critical powder had not received a required on-site audit, that it was last evaluated in September 2020 and that there was no signed quality agreement. The firm's responses described a manufacturing and process hold, inspection of existing inventory, a field action for humeral shoulder liners and corrective actions under several CAPAs; FDA found most of them inadequate. A trade report noted that the inspection took place before the asset sale was approved and before Advita Ortho was launched, and that it also found incomplete documentation of production events between July 2023 and July 2025. ^{1 2}

analysisThe Settlement Trust's complaint states that FDA's March 2017 inspection produced seven observations, including that Exactech had no established procedures for handling complaints and did not adequately investigate 19 of 24 complaints received from November 2013 to February 2017, and that TPG appears to have had access to these results during due diligence. It presents 20 FDA citations from 2017 to 2023, 13 of them after the acquisition, and describes a January 2020 inspection that found inadequate purchasing, design transfer, validation and verification procedures. ¹

analysisAccording to the complaint, an inspection from November 8 to 17, 2021 found that Exactech had not implemented requirements to prevent oxidation, had never validated its implant packaging and had no procedures for accepting incoming products from suppliers; FDA is quoted as finding that the bags did not contain EVOH as the drawing required, that non-conforming product had been shipped to Exactech for 17 years and that receiving staff accepted the bags without checking certificates of conformance. The trust reproduces observations that about 1,405,000 devices had been made since February 2007 with a vacuum-sealing process that was not adequately validated, alleges that around 2007 Exactech extended the shelf life of its knee inserts from five to eight years without reporting it to FDA, and says that in September 2023, after three recalls covering over 627,000 units, Exactech failed another inspection. It adds that Exactech cleared vitamin E hip liners in March 2018 but no vitamin E knee device until the Truliant in July 2023. These are allegations in the Settlement Trust’s pending complaint and have not been adjudicated. TPG told a newspaper in May 2025 that it was "categorically false" that it had any prior knowledge of the packaging nonconformance. ^{1 2}