OIG - Office of Inspector General
11/17/2025 | Press release | Archived content
Aesculap Implant Systems LLC
Location Center Valley, PA Settlement Amount $38,500,000
Although Aesculap Implant Systems LLC (Aesculap) entered into a health care fraud settlement with the United States, Aesculap refused to agree to compliance-related oversight with HHS-OIG through a CIA. Therefore, as part of the Settlement Agreement, OIG reserved the right to exclude Aesculap for the alleged conduct. Because Aesculap refused appropriate integrity obligations with OIG, OIG may use various tools to monitor Aesculap's compliance with the Federal health care programs.
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Aesculap Implant Systems Agrees to Pay $38.5 Million to Resolve False Claims Act Allegations Related to Knee Implant Failures
November 17, 2025Published by the United States Department of Justice | View article on www.justice.gov
Company Also Enters Into Non-Prosecution Agreement Related to the Introduction of Two Adulterated Medical Devices Into Interstate Commerce
PHILADELPHIA - United States Attorney David Metcalf and the Department of Justice announced today that medical device company Aesculap Implant Systems, LLC ("Aesculap"), based in Center Valley, Pennsylvania, has agreed to pay $38.5 million to resolve allegations under the False Claims Act that the company sold knee replacement devices that it knew would fail prematurely at a higher than acceptable rate, resulting in false claims to Medicare and Medicaid. The settlement further resolves allegations that the company paid unlawful remuneration to a physician to induce him to use the knee implants. Additionally, Aesculap agreed to a non-prosecution agreement with the United States in connection with its distribution of two medical devices without the required clearance from the U.S. Food and Drug Administration (FDA).
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