Orthosoft, Inc. dba Zimmer CAS

CLOSEOUT LETTER Orthosoft, Inc. dba Zimmer CAS MARCS-CMS 496307 — August 02, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Louis-Philippe Amiot Recipient Title Vice President and General Manager Orthosoft, Inc. dba Zimmer CAS 3300-75 Queen Street Montreal H3C 2N6 Canada Issuing Office: Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Louis-Philippe Amiot: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 496307, dated May 27, 2016). 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/ CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 08/06/2019 Regulated Product(s) Medical Devices