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  5. Orthosoft, Inc. dba Zimmer CAS - 496307 - 08/02/2019
  1. Warning Letters

CLOSEOUT LETTER

Orthosoft, Inc. dba Zimmer CAS MARCS-CMS 496307 —

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