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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00161-1
Product Name/Description	Cereform Silicone Gel filled Breast Implants and Corresponding Sizers ARTG Number: 165462, 165461, 165460 and 162029
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	6/03/2014
Responsible Entity	Medical Vision Aust Plastic & Cosmetic Pty Ltd
Reason/Issue	French regulatory body, ANSM after an inspection of the manufacturing facility determined that the validation of the sterilisation provider was not consistent with the requirements of international regulatory standards. Therefore, sterility of the Cereform Breast Implants and Corresponding Sizers cannot be fully assured. Cereplas was in the process of validating a new sterilisation provider but due to the lengthy process of such validation Cereplas did not meet the deadline set by the French regulatory body ANSM resulting in suspension of the CE certificate on the 10th February 2014. The suspension remains in place until the sterilisation validation with the new provider is completed and accepted by ANSM. Following the suspension of the CE certificate ANSM requested that all non-implanted Cereform products be recalled in France clearly stating the recall was based on the licensing and regulatory issue and NOT a “sanitary” (safety) issue.
Recall Action	Recall
Recall Action Instructions	Medical Vision Australia Plastic & Cosmetic Pty Ltd has recalled all the non-implanted stock and is returning the recalled stock and all stock under their control to the manufacturer Cereplas, France. For more details, please see http://www.tga.gov.au/safety/alerts-device-cereform-breast-implants-140311.htm .
Contact Information	1300 661 559 - Medical Vision Australia Plastic & Cosmetic