Events

Safety Alert for Name of Endodontic Resuscitation Name: Disposable Blades ANVISA Registration Number: 80804050138 Hazard Class: II Affected Model: 7205305 - Endoscopic Resuscitation FULL RADIUS 3.5mm Straight Beige Serial Numbers Affected: 50983335, 50983334, 50977889, 50975556, 50970649, 50968791, 50964650, 50961735 and 50952320.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Smith & Nephew Comércio de Produtos Médicos Ltda.; Smith & Nephew, Inc. - Endoscopic Division.

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
    2175
  • Date
    2017-02-08
  • 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
    1. Locate and immediately quarantine the unused affected devices. 2. Return the quarantined product to Smith & Nephew's national agency or distributor. 3. Fill out the return form and send it by email to the Smith & Nephew national distributor. 4. Ensure that this safety information is passed on to all who need to be aware of it within your institution. 5. Observe this notice, as well as the resulting action, until the corrective security action is completed to ensure its effectiveness.
  • Reason
    Smith & nephew, inc. has initiated a field correction for several batches of full radius ™ blade 3.5mm due to a manufacturing error. the product was produced with a black ultem blade insert, instead of blue polycarbonate.
  • Action
    Field Action Code 001/2017 triggered under the responsibility of Smith & Nephew Comércio de Produtos Médicos Ltda. Company will collect.

Device

Name of Endodontic Resuscitation Name: Disposable Blades ANVISA Registration Number: 80804050138 ...

Manufacturer

Smith & Nephew Comércio de Produtos Médicos Ltda.; Smith & Nephew, Inc. - Endoscopic Division