Safety Alert for Femoral Rod Beaded Fc 6 "14/15/16/17 / 18x160mm Technical Name: Non-modular rod for hip arthroplasty ANVISA Registration Number: 80245480039. Risk Class: III Affected Model: 7843-14- 06, 7843-15-06, 7843-16-06, 7843-17-06, 7843-18-06, 7843-20-06. Affected serial numbers: 784301706 107163; 784301806 60464838; 784301706 60684165; 784301806 60795256; 784301406 61064829, 784301606 61246702, 784301606 61250415, 784301506 61405041, 784301406 61410287, 784301506 61652527, 784301506 61669558, 784301406 61714435, 784301406 61714435, 784301706 61813371, 784301706 61813371, 784301806 61886033, 784301806 61886033, 784301506 61941406, 784301506 62029066; 784301806 62034164. 784301806 62034164 ; 784301506 62143767, 784301606 62147264, 784301606 62147264, 784301406 62271353, 784301406 62302689, 784301506 62335828, 784301506 62379188, 784301506 62445614, 784301506 62445614, 784301506 53493900, 784301606 57912000, 784301406 60329445, 784301706 60946005, 784301806 60 966723; 784301606 61000224; 6,840,038; 784301506 61198821; 784301406 61215303; 784301406 61215303; 784301506 63730100

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.

Report adverse effects related to these products in Brazil directly to the local sales representative, or: On line: www.wmie.com.br, or www.anvisa.gov.br, or www.fda.gov/medwatch/report.htm , or Tel / Fax: 21 2210-2620 E-mail: sac@wmie.com.br, or zimmer.per@zimmer.com. If after reading this notification you have further questions please contact your local Zimmer dealer, or WM 21 2210-2620 (Monday - Friday from 8:30 am to 6pm), or Zimmer SAC 1-877-946-2761 Additional Information: This Recall voluntary was reported to ANVISA and to the US Food and Drug Administration If you want to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AEs) 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 Additional information: - Date of identification of the problem by the company: 09/28/2017 - Date of notification notice to Anvisa: 10/6/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "