Safety Alert for Technical Name: Non-absorbable tubular angled plate for osteosynthesis ANVISA Registration Number: 80034760050 Hazard Class: III Model Affected: 2266-318-095 Serial Numbers Affected: 00107967/006939 - 08 units - Date of manufacture: 01/14/2016 00109330/006939 - 08 units - Date of manufacture: 01/14/2016 00107963/006939 - 11 units - Date of manufacture: 01/14/2016 00110188/006939 - 11 units - Date of manufacture: 01/14/2016 00107966/006939 - 04 units - Date of manufacture: 01/14/2016

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.

Non-deployed products should be segregated and returned to the company Meta Bio, which is discontinuing the plates above 16 holes, due to low commercialization and the need to use a product with this extension. We recommend to users and patients that, if there is any type of technical complaint and adverse event involving the products mentioned in this Field Action, it must be reported to the Distributor and / or to the Meta Bio Manufacturer and / or through the NOTIVISA System. To the users, it is confirmed that it is not necessary the clinical follow-up of patients already implanted, since it is an implant with temporary function, that is, it is destined to stabilization and fixation of the fracture until osseointegration occurs, past this period the implant loses its function.