BfArM - Federal Institute for Drugs and Medical Devices

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Biointegral Surgical Inc. - all products

Product group Non-active implants - cardiac surgery
Reference 09058/22

The German distributor SyGan (Berlin) informed the BfArM about the recall, respectively withdrawal of all products of the company Biointegral Surgical Inc. from the German market. The products in question are cardiological and vascular bioprostheses. For the risks associated with the products, we refer to the statements of the professional societies https://www.dgthg.de/de/hcu.

Biointegral Surgical Inc. - all products, Download_VeroeffentlichtAm_EN

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