Aesculap Implant Systems Resolves Long-Pending Federal Investigations

CENTER VALLEY, Pa., Nov. 17, 2025 /PRNewswire/ -- Aesculap Implant Systems, LLC ("AIS"), a medical device company based in Center Valley, Pennsylvania, today announced the resolution of federal investigations into matters dating back over eight years through two agreements with the United States Department of Justice ("DOJ"). AIS is grateful to DOJ's Civil Division leadership and the United States Attorney's Office for the Eastern District of Pennsylvania for bringing closure to these long-pending matters.

The investigation stemmed from AIS's discovery and voluntary disclosure in 2017 of the unauthorized distribution of two medical devices between March and August 2017, because of the fraudulent actions of a former employee who misrepresented that clearance from the Food and Drug Administration ("FDA") had been obtained for the devices. Upon discovering the misconduct, AIS promptly notified the FDA, terminated the employee, initiated a recall and fully reimbursed all purchasers. AIS subsequently obtained FDA clearance for both devices. No patient harm was reported. The company was recognized by the court as the victim of the fraud.

In January 2024, the former employee pleaded guilty to one felony count of violating the Federal Food, Drug, and Cosmetic Act. The individual was sentenced to 12 months in prison and ordered to pay restitution to AIS.

Although the distribution of uncleared medical devices constitutes a strict liability misdemeanor, DOJ, through its Consumer Protection Branch, agreed not to pursue criminal charges against AIS, subject to the terms of a Non-Prosecution Agreement. This agreement reflects AIS's full cooperation with the investigation, including conducting an internal review with improvements made to internal processes, reporting the misconduct to federal authorities, providing evidence to law enforcement and responding promptly to government requests. AIS is committed to continuing to cooperate fully with DOJ to successfully complete the terms of the agreement.

The second agreement is a civil settlement with the DOJ and the United States Attorney's Office for the Eastern District of Pennsylvania that resolves two longstanding whistleblower cases—dating back nearly a decade—which alleged False Claims Act violations. The settlement addresses products that AIS no longer sells, the Vega System® Knee System ("Vega System") and the allograft tissue product and a physician consulting arrangement that ended in 2017. These allegations were largely addressed in earlier product liability litigation, which the company vigorously defended resulting in more than half of the cases being dismissed as without merit. The company denies the DOJ's and Relators' contentions, including that it knowingly caused the submission of false claims to any payor. AIS has entered into this agreement only to avoid the delay and expense of protracted litigation. AIS stands by its products which were tested extensively before being released for sale.

Vega System knee implant has been successfully used in thousands of patients across the United States since its introduction in 2010, and thousands more worldwide have also benefited from this product. The Vega System has never been subject to a recall. Loosenings, which can happen for many reasons, including surgical technique and patient-specific conditions, are an inherent and unavoidable risk of all knee implants. When it became evident that some surgeons were not following company recommendations or bone cement manufacturer instructions, AIS updated the Vega System's surgical technique guide and provided training on proper cementing techniques between 2018 and 2019.   

AIS continues to maintain that it did not knowingly cause false claims of any kind to be submitted to the federal government and maintains the safety of its products. The company remains committed to maintaining a culture of compliance and continued cooperation with the government.

SOURCE Aesculap, Inc.