Mentor Worldwide LLC

CLOSEOUT LETTER Mentor Worldwide LLC MARCS-CMS 573520 — May 03, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Alenka Brzulja Recipient Title Worldwide President Mentor Worldwide LLC 31 Technology Drive Irvine , CA United States Issuing Office: Center for Devices and Radiological Health United States Dear Alenka Brzulja: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS Case# 573520, dated March 18, 2019). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Binita S Ashar, MD, MBA, FACS Director OHT4 Office of Surgery and Infection Control Devices Office of Product Quality and Evaluation Center for Devices and Radiological Health U.S. Food and Drug Administration Content current as of: 05/15/2023 Regulated Product(s) Medical Devices