Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Mentor breast implants

21 May 2013

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning breast implants manufactured by Mentor. The affected sales code and lot number are 3545160 and 5741158 respectively, with expiry date in May 2012.

The manufacturer has identified an issue where one lot of these products was inadvertently shipped out beyond its expiration date because of a scanning error in the company's inventory and distribution system. The affected lot may contain a secondary inventory label with an incorrect expiry date (different from the product label). To date, no complaints have been reported that are connected to this issue.

The manufacturer advises users to immediately identify and quarantine all unused product and return them to their supplier For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON273701

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 21 May 2013

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