Events

Safety Alert for CORTICAL BOLT SCREW 4.5MM MDN, model 2253-XX-45. Registration 80245480011

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
    1590
  • Date
    2015-05-26
  • 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
    The company informs that Zimmer received a single claim in the world that could possibly be attributed to this dimensional incompatibility of the 4.5mm M / DN bolt. No injury injury or injury to the patient as a result of the incident was reported. The occurrence estimate is 0.00033%. In Brazil, among the 122 units implanted there was no adverse event reported. The company directs health services to report any adverse events.
  • Reason
    Zimmer is starting a recall of the 4.5mm cortical bolts of the m / dn system because it was found during the revision of the historical project files that the entire scope of 4.5mm m / dn cortical bolts could present dimensional incompatibility with the m system / dn. dimensional incompatibility can occur only in the worst case of plant specifications, where multiple dimensional parameters are within the maximum material limits (it means that the stem bore is smaller than possible and the outer diameter of the bolt is as wide as possible). the affected items were distributed from january 2006 to february 2015.
  • Action
    1. Ensure that affected personnel are aware of the information; 2. Locate all affected products in Annex 1 and remove them from use immediately (segregation / quarantine); 3. The local sales representative Zimmer will make the recall the affected products; 4. Complete the "Acknowledgment of Responsibility Form" and send to - corporatequality.postmarket@zimmer.com and / or sac@wmie.com.br; 5. If after reviewing this notice you have additional doubts please contact your local Zimmer dealer. Adverse effects related to these products in Brazil should be reported directly to the local sales representative, or www.wmie.com.br and through NOTIVISA.

Device

CORTICAL BOLT SCREW 4.5MM MDN, model 2253-XX-45. Registration 80245480011

Manufacturer

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