Events

Safety Alert for Trade name: MDN FEM Long and Versa FX Supracondylar 16-20 F Registration number ANVISA: 80245480016, 80245480014 Hazard class: III Serial numbers affected: 00368898; 00368898R; 00370907; 26060100V; 60518281; 60812398R; 6,157,7082; 62351559; 62445941; 62539606; 62930529; 37214361; 60165193; 60482973; 60533011; 6,251,128; 37109081; 60598295; 24397300V; 60680624; 60758098; 61307908; 61413333; 61313655; 60732923; 61357112; 60615904; 6,114,354; 6,114,828; 61389801; 60615906; 22195400V; 60565839; 61450097; 22299700; 6,142,220; 60477024.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by WM WORLD MEDICAL IMP EXP LTDA; ZIMMER INC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2292
  • Date
    2017-05-17
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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 additional doubts please contact your local Zimmer distributor, or WM 21 2210-2620 (Monday - Friday from 8:30 am to 6pm), or Zimmer SAC 1-877-946-2761 Additional Information: This Recall volunteer was reported to ANVISA and the US Food and Drug Administration (FDA)
  • Reason
    Zimmer biomet is initiating a voluntary recall of some sterile implants due to the possibility of packing failure, the affected products are the longer length rods, the manufacturer zimmer biomet is collecting the potentially affected products remaining in stock. the affected lots were distributed to brazil since aug / 2007 and no injury or damage was reported for this event.
  • Action
    Field Action Code ZFA - 2017 - 139 triggered under the responsibility of the company WM WORLD MEDICAL IMP EXP LTDA. Company will make collection for later return to the manufacturer.

Device

Trade name: MDN FEM Long and Versa FX Supracondylar 16-20 F Registration number ANVISA: 802454800...

Manufacturer

WM WORLD MEDICAL IMP EXP LTDA; ZIMMER INC
  • Source
    ANVSANVISA