Alerta De Seguridad para INSTRUMENTAL FOR HYGIENE SURGERY. Registro ANVISA n ° 80005430185 .. Units affected: see Alert Message published by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/e1bfcf804cf2a50fbe9ebe551355428f/Mensagem_de_Alerta_.pdf?MOD=AJPERES.

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.

According to the company, there is a potential danger associated with this product field action: presence of a metal fragment in the internal screwed part of the conical body. There are two predictable sequences of events associated with the presence of a metal fragment: (a) In the first, the fragment falls into the wound and is observed by the surgeon. The dangerous situation is the extra time to remove the fragment. The associated potential risk is an extended surgery time of less than 30 minutes; (b) In the second predictable sequence of events, the fragment falls into the wound and is not observed by the surgeon. The dangerous situation is the fragment being implanted in the patient. The associated potential risk is a localized biological response. As a risk mitigation measure, a field action of the product is being conducted to investigate the presence of the metal fragment. For instructions on completing the Product Field Action Science Form and other information, consult the Company Alert Message at http://portal.anvisa.gov.br/wps/wcm/connect/e1bfcf804cf2a50fbe9ebe551355428f/Alerta_Message_.pdf? MOD = AJPERES #### Update (13/11/2012): According to Sryker, all affected customers have already been informed and no nonconformities have been detected in the products under risk in Brazil. The field action was closed by the company on 11/09/2012.