Safety Alert for Trade name: Insertion Handle PFN / PFNA //. Technical Name: INSTRUMENTAL NON-JOINT NON-CUTTING //. ANVISA registration number: 80145901733 //. Risk class: I - Low Risk //. Model: INSTRUMENTAL //. Products Affected: Code: 357.012 || Lot: 1939597, 1959882, 3087336, 3061690, 3167213, 9291777, 3115141, 3220493, 1860810, 3073276, 3007247, 1998945.

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.

If you have any of the affected products identified, follow these steps: • Ensure that all persons in your facility who may be involved in this notification are able to read this letter carefully. • Immediately identify and quarantine all products listed below and not used in order to ensure that the affected products are not used. • Keep a copy of this notice with the affected product (s) listed above. • Fill in the Verification Section (page 4 of this letter), marking the appropriate field to indicate that the affected product was found. Also, indicate the number of devices found and your Lot Number. Enter your name, title, address, phone number and signature in the spaces provided. • Return the completed Verification Section to your local DePuy Synthes contact. • Contact your local DePuy Synthes sales organization to arrange for the return of the affected devices and to obtain a free replacement. If you DO NOT have any of the affected products identified, follow these steps: • Complete the Verification Section (page 4 of this letter) by checking the appropriate field to indicate that the affected product was not found. Enter your name, title, address, phone number and signature in the spaces provided. This documentation return confirms that you received the recall information from the medical device. • Return the completed Verification Section to your local DePuy Synthes contact. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link