Exactech Knee Recall Lawsuit

Exactech voluntarily initiated a recall of affected knee, hip, and ankle replacement components in August 2021 after identifying that PE liners had been packaged in non-conforming single-layer bags lacking an inner oxygen barrier. The FDA assigned a Class II recall designation, indicating a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Affected devices included Optetrak, Optetrak Logic, and Truliant knee systems, as well as select hip and ankle components.

Exactech dramatically expanded its recall in February 2022 to include approximately 147,000 affected devices across multiple product lines in the United States, plus additional patients worldwide. The expanded recall encompassed all major Exactech joint replacement lines: Optetrak, Optetrak Logic, and Truliant knee systems; Alteon, Novation, and Connexion hip systems; and the Vantage total ankle replacement system. Exactech issued updated physician and patient letters urging surgeons to identify affected patients and arrange for clinical evaluation and imaging follow-up.

The FDA confirmed its Class II recall classification for the Exactech devices, placing the recall in the agency's enforcement database and MedWatch recall system. Unlike a Class I recall (which indicates a reasonable probability of serious adverse health consequences or death), Class II indicates the lower-tier risk designation — a classification criticized by patient advocates and plaintiffs' attorneys who argue the oxidative degradation risk and revision surgery burden warrant Class I status. The FDA's CDRH division opened a review of Exactech's post-market surveillance obligations.

Following the recall, the FDA's Center for Devices and Radiological Health (CDRH) initiated review of Exactech's 510(k) substantial equivalence clearances for the recalled devices to assess whether the packaging defect constituted a material change that should have triggered a new 510(k) submission. Plaintiffs' attorneys have argued that Exactech's continued use of non-conforming packaging without notifying the FDA or filing a supplemental 510(k) constitutes negligence per se and supports failure-to-warn and fraud theories.

Following its public listing, TPG Capital was required to disclose in SEC filings the financial impact of the Exactech recall, including recall-related costs, legal reserves, and potential litigation exposure. Public filings acknowledged the recall but did not disclose specific settlement reserve amounts. Plaintiffs' attorneys have used these disclosures in litigation to argue that TPG Capital — as the private equity owner with board-level oversight — bears direct liability alongside Exactech for the packaging defect and its consequences.