US EditionAesculap Implant Systems Resolves Long-Pending Federal Investigations
Aesculap Implant Systems resolved nearly decade-old False Claims Act allegations and a Non-Prosecution Agreement after a former employee’s FDA clearance fraud, DOJ said.
- On Nov. 17, 2025, Aesculap Implant Systems, LLC announced it resolved federal investigations through two agreements with the Department of Justice to avoid lengthy litigation, including a civil settlement addressing two whistleblower False Claims Act cases.
- AIS discovered and voluntarily disclosed in 2017 unauthorized distribution involving two devices and a physician consulting arrangement tied to fraud by a former employee, with a court recognizing AIS as the victim.
- A former employee was sentenced to 12 months in prison with restitution ordered, after the investigation, while DOJ's Consumer Protection Branch approved a Non‑Prosecution Agreement after AIS cooperated.
- DOJ's Civil Division and the United States Attorney's Office for the Eastern District of Pennsylvania resolved the suits, and AIS committed to ongoing cooperation, internal review and process improvements.
- The settlement covers products the company no longer sells, and AIS updated the Vega System surgical technique guide and training to address surgeon practices.
27 Articles
27 Articles
The Daily News - Jacksonville, NC
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…
Aesculap settles federal investigations
Center Valley-based medical device company, Aesculap Implant Systems, LLC said it has resolved federal investigations into matters dating back over eight years through two agreements with the United States Department of Justice. The company said the investigation stemmed from AIS’s discovery and voluntary disclosure of the unauthorized distribution of two medical devices between March and August 2017, because of what it described as the fraudul…
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