Exactech's polyethylene recalls and the FDA

analysisIn its 2024 bankruptcy declaration the company said that, in coordination with the FDA, it had voluntarily recalled Connexion GXL hip liners from June 2021, then all hip liners and knee and ankle implants, and in early 2024 shoulder devices and knee patella components, because a vendor had supplied packaging bags missing one of seven specified layers, an oxygen barrier protecting the polyethylene from oxidation. ^{1 2}

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.

analysisThe FDA's safety communication of 23 March 2023 warned that knee, ankle and hip devices made between 2004 and August 2021 had been packaged in defective bags that could lead to oxidation, accelerated wear, cracking and revision surgery, and recorded the stages of the recalls: GXL liners in June 2021, all affected knees and ankles from February 2022 — about 80% of those made since 2004 — and all affected hip devices from August 2022. A second communication in January 2024 said that Equinoxe shoulder implants had been packaged in the same bags and that Exactech had so far declined to recall them. ^{1 2}

outcome

Exactech initiated the shoulder recall in 2024: the FDA's update of 19 April 2024 reports it, and the FDA enforcement record dates the recall event (94092) from 6 March 2024.

analysisThe FDA's enforcement records list the polyethylene recalls as Class II events with Exactech, Inc. as recalling firm, among them 89,050 GXL hip liners from June 2021, 109,787 Optetrak Logic and 31,201 Truliant knee inserts from August 2021, shoulder liners and glenoids from March 2024, patella components from April 2024 and XLE hip liners from December 2024. They also record unrelated recalls, such as a 2012 shelf-life labelling error and, in 2025 and 2026, shoulder liners outside their dimensional specification and surgical instruments. ^{1 2 3 4}

analysisAfter a September 2023 inspection in Gainesville the FDA's warning letter of 19 January 2024 found shoulder systems and other implants adulterated, because the firm had not identified the actions needed to correct shoulder implants in non-conforming bags and had counted only some complaints in its hazard evaluation, and misbranded, because a report of accelerated liner wear had reached the FDA late. A second letter of 19 December 2025, addressed to 'Exactech, Inc. dba Advita Ortho' after a July 2025 inspection in Sarasota, faulted the control of the sole supplier of a polyethylene powder and other quality-system failures. ^{1 2 3 4}

qualification

Which legal entity is behind the name 'Exactech, Inc. dba Advita Ortho' is not stated in the letter; the inspection preceded the sale of the business to Advita Ortho.

response

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. The firm told the FDA that it had suspended production, started a field action on humeral shoulder liners and opened a corrective action (CAPA 2025-30) for the Sarasota and Gainesville sites due for completion by March 2026; the FDA found the responses not adequate.

outcome

Exactech initiated the shoulder recall in March–April 2024.

analysisThe FDA's registration database still lists the Gainesville plant under Exactech, Inc., and its most recent 510(k) clearance, of April 2026 for the Equinoxe shoulder, names Exactech, Inc. as applicant and Advita Ortho as correspondent. A national newspaper reported in 2025 that Australian joint-registry reports from 2011 to 2018 had found 'higher than anticipated' revision rates for Exactech devices. ^{1 2 3 4 5}

qualification

The FDA records keep the Exactech, Inc. name after the sale of the business; they do not state which legal entity now holds the registration. The registry reports themselves were not retrieved; the figures are as reported by the newspaper.

response

In its October 2024 bankruptcy declaration the company said it has consistently maintained that the non-conforming packaging has not led to overall higher rates of revision surgery beyond industry averages (5–10% at ten years of follow-up), and that scientific and clinical data support its position; the newspaper reported the same position from the company's court disclosures.