Clipping of news on Brazilian Culture, Law and Citizenship
12/23/2014
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December 22, 2014
Anvisa suspended on Monday (22/12), import, distribution, marketing and implant Breast Implant Silicone Arion, manufactured by French company Laboratoires Arion and recorded by imact Import e Comércio Ltda.
The determination covers the prosthesis sterilized by ethylene oxide - made from 28.04.2014 - and dry heat. An audit at the plant on 28 and 04/29/2014 found that the sterilization method used is at odds with the record in product registration. The Quality Falcão Bauer Institute suspended the Authorization for Use of the product Conformity Identification Mark.
Despite the irregularity, the prosthesis presents no risk to the health of patients that already have deployed product.
The company imact Import and Trade Ltd. is responsible for promoting the collection of existing stock on the market for the product mentioned above.
The measure was published in the Official Gazette (DOU). Click here to read the full Resolution No. 4,881 / 2014.
Source: ANVISA
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This article was translated by an automatic translation system, and was therefore not reviewed by people.