Alerta De Seguridad para Sinus SuperFlex 635 - Registration 80134860182 - Risk Class III (High Risk) -Model: Length 200 mm - Lots Q010281; Q012048; Q012989; Q014025; Q016213; Q011544; Q011147; Q013879; Q016211; Q17591; Q020471; Q018124; Q018684 - Reference Numbers / Product Description: (i). 8606-6200 / sinus-SuperFlex-635, Stent System, 6x200mm, 6F / 75 cm, .035i, application device; (ii). 8606-7200 / sinus-SuperFlex-635, Stent System, 6x200mm, 6F / 120 cm, .035i, application device; (iii). 8607-6200 / sinus-SuperFlex-635, Stent System, 7x200mm, 6F / 75 cm, .035i, application device; (iv). 8607-7200 / sinus-SuperFlex-635, Stent System, 7x200mm, 6F / 120 cm, .035i, application device. (Distribution Map in ANNEX)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company clarifies: 1. Only the products listed in the response letter are affected by this recall action; 2.Affected products should be listed in your inventory and segregated in a way that is not used. These products should not enter into clinical use; 3. Disclose to the entire company team this Collection Camp action; 4. Customers must complete the response letter, informing the quantity of products that will be returned and the number of units already used. Inform reference and lot; 5. The Response Letter must be completed and signed and returned by fax, email or post within 10 days of receipt; 4. The response letter must be returned to the company even if there are no units of the product to be returned; 5. Return only the products affected by this Gathering Action. The credit memo will be provided for all returned sterile products; 6. Questions and additional questions related to the return of the products, credit note, replacement or shipment, must be passed to the sales representative of the company or directly to the holder of the registration of the product; 7. If the products have been marketed to another company (s), please send a copy of this information to the company or inform the registration holder of the contact persons; 8. It is fundamental to collaborate with all the distribution chain and use of the product affected by the present action of Recolhimento.