The packaging defect and the polyethylene recalls, 2021–2025

analysisAccording to the chief restructuring officer's declaration, Exactech recalled its Connexion GXL hip liners from June 2021, later extended the recalls to all hip liners and knee and ankle implants, and in early 2024 recalled shoulder devices and knee patellar components; in coordination with FDA it recalled all tibial knee inserts, patellar components, GXL and conventional hip liners and shoulder glenoids and liners distributed in non-conforming packaging. The declaration says the recalls were voluntary and that the cause was bags, made and supplied by outside vendors, that lacked one of seven specified layers, the one providing an oxygen barrier to protect the polyethylene from oxidation. An FDA safety communication of March 23, 2023, updated in August 2024, warned that knee, ankle and hip devices made from 2004 to August 2021 and packaged in such bags could oxidise, wear faster and fail, leading to revision surgery. ^{1 2}

analysisThe Settlement Trust's complaint states that from 2004 until mid-2021 the polyethylene was made in Sarasota and Gainesville and was supposed to be packaged in oxygen-resistant vacuum bags containing an ethylene vinyl alcohol (EVOH) layer before going to an outside sterilisation company. It identifies the affected products as the Equinoxe reverse and anatomic shoulders, the MCS, AcuMatch, Novation and Alteon hips, the Optetrak, Optetrak Logic and Truliant knees and the Vantage ankle. These are allegations in the Settlement Trust’s pending complaint and have not been adjudicated. ³

analysisFDA's recall database records the first recall, of Connexion GXL liners (Novation GXL and AcuMatch GXL, recall Z-2132-2021, event 88126), initiated by Exactech on June 29, 2021 and posted on July 22, 2021: the firm cited a possible risk of edge-loading and premature wear in a subset of patients, the root cause was recorded as not determined by the firm, and 89,050 units were in commerce. In August 2022 the hip recall was widened to all hip devices with polyethylene in defective packaging; FDA lists an AcuMatch GXL and MCS GXL item of 11,143 devices begun on August 11, 2022, and the Judicial Panel on Multidistrict Litigation noted that the expansion covered about 40,000 Connexion GXL and conventional liners. FDA said it was evaluating other Exactech implants and working with foreign regulators. ^{1 2 3 4}

analysisFurther hip recalls followed: an AcuMatch item after complaints of lost vacuum in the inner bag (November 2023); 589 AcuMatch L-Series bipolar liners packaged without the EVOH layer (April 2024), when the firm stated that between 2004 and August 2021 it had used two packaging types, one with and one without EVOH; and, after the bankruptcy filing, AcuMatch, Novation and Alteon XLE liners begun on December 31, 2024. ^{3 5}

analysisOn August 30, 2021 Exactech began recalling knee and ankle inserts packaged in vacuum bags lacking the additional oxygen barrier; FDA classified the recall as class II on October 4, 2021, listing 109,787 OPTETRAK Logic and 31,201 TRULIANT tibial inserts among its items. According to FDA, on February 7, 2022 Exactech extended the recall to all Optetrak, Logic and Truliant knee and Vantage ankle replacements packaged in defective bags regardless of shelf life, and about 80% of the knee and ankle devices made since 2004 had been packaged in such bags; an updated urgent medical device correction followed on April 7, 2022. Patellar components were recalled from April 18, 2024. ^{1 2}

analysisAn FDA safety communication of January 16, 2024 warned about Equinoxe shoulder systems made from 2004 to August 2021 in defective bags and stated that Exactech had so far declined to start a voluntary recall; FDA's update of April 19, 2024 reports that Exactech had begun a recall to remove unused devices from facilities' inventories. FDA's enforcement data record recalls of Equinoxe humeral liners and posterior augment glenoids from March 6, 2024 for the missing EVOH layer, and in August 2025 of reverse-shoulder humeral liners, 61,334 and 11,542 units, whose articular surface was outside the labelled dimensional specification. ^{1 2 3}

analysisFDA's data continue to name Exactech, Inc. of Gainesville as the recalling firm after the 2025 asset sale: a recall of Equinoxe Ergo instruments begun on September 5, 2025 because devices that had not passed a design update and testing were released, and recalls of an Equinoxe Ergo impactor handle (120 units) and Equinoxe core instrument kits (596 kits) begun on February 3, 2026 because a cross pin might be missing. As of October 7, 2026 openFDA held 11 enforcement entries for Exactech recalls begun between April 19, 2024 and October 16, 2026, all class II. ¹

analysisThe trust alleges that Exactech ran a series of recalls each covering only part of a product line, to keep sales looking stable and support TPG's IPO plans: the June 2021 GXL recall was first limited to liners implanted after 2015, and the August 2021 knee and ankle recall to devices with a shelf life over five years. It says the shelf-life proposal went to FDA on August 24, 2021 and that FDA replied within four days that it might not rest on relevant and reliable data and did not cover all liners in non-conforming bags, so that Exactech widened the knee and ankle recall in February 2022 after being pressed by FDA. It alleges that the August 2021 recall was sent to distributors and sales representatives rather than to providers or patients, that a 2022 letter acknowledged GXL liners had been in out-of-specification bags since 2004, and that XLE liners sold since 2018 were not recalled until December 2024. These are allegations in the Settlement Trust’s pending complaint and have not been adjudicated. Exactech has maintained in its bankruptcy filings that it recalled in an abundance of caution and that the bags did not raise overall revision rates beyond industry averages; TPG told a newspaper in 2025 that the packaging issues predated its ownership, that it learned of them in 2021 and supported the investigation and voluntary recall. ^{1 2 3}

analysisAccording to the complaint, by August 18, 2021 Binder and Schilling had displaced many of Exactech's key regulatory staff and, helped by Garrison, Bennett Yasskin, Michael Tepatti and John Lin, took the lead on the recall project, and at a September 2021 meeting with FDA Binder acknowledged that the GXL liners were "not state of the art" while pressing for the GXL inventory not to be recalled in full. Binder has said that Exactech's own complaint investigations led it to discover the non-conformity in 2021 and that it reported it to FDA and launched a recall. These are allegations in the Settlement Trust’s pending complaint and have not been adjudicated. ¹

analysisThe trust counts more than 70 products and nearly 800,000 units in commerce in the pre-petition polyethylene recalls, seven recalls that it says made up nearly 90% of recalled units among Exactech's 68 recall events, and tabulates event 88126 (89,050 units), event 88570 (430,517 units in commerce), event 90279 (107,529) and event 94092 (171,322); FDA's own entries give different per-item quantities. It also recounts the March 2023 and January 2024 safety communications and the April 2024 patella recall. These are allegations in the Settlement Trust’s pending complaint and have not been adjudicated. ¹

analysisA newspaper reported in May 2025 that annual reports of the Australian joint replacement registry from 2011 to 2018 had identified Exactech devices as having "higher than anticipated" revision rates and that the 2016 report found the Optetrak PS knee's ten-year revision rate more than four times the overall rate; the registry reports themselves are not in the retained record. Exactech has maintained that the non-conforming bags did not raise overall revision rates beyond industry averages, a position it says scientific and clinical data support. ^{1 2}