Events

Safety Alert for Commercial Name: Maxillofacial Distraction System Technical Name: Bone Distrator ANVISA Registration Number: 80145901599 Hazard Class: III Affected Model: Distr. Mandib. Monoaxial Serial numbers affected: Code: 487.962 || Lot: 6164423, Quantity: 1 item and Lot: 7537258, Quantity: 5 items Code: 487.963 || Lot: 7865438 || Quantity: 10 items Code: 487.964 || Lot: 5559854, Quantity: 1 item and Lot: 5868674, Quantity: 1 item. Code: 487.965 || Lot: 5859710 || Quantity: 1 item. Code: 487.974 || Lot: 5354033, Qty: 3 items; Lot: 5860826, Qty: 1 item and Lot: 6044556, Qty: 4 items. Code: 487.975 || Lot: 6107609, Qty: 7 items; Lot: 6164420, Qty: 4 items and Lot: 5847302, Qty: 1 item.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH.

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
    2103
  • Date
    2016-10-06
  • 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
    There is no DePuy Synthes replacement device available. Synthes GmbH offers a number of alternative devices that are also indicated for jaw distraction, including the Stainless Steel Mandibular Distrator System, the Titanium Multivector Distrator Module System and the Curvilinear Distraction System. Refer to the Indications and Instructions for Use for these alternative systems to determine suitability for your patients.
  • Reason
    The mandibular distrator screw can detach prematurely from the proximal base plate.
  • Action
    Field Action Code R410682 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make collection for later return to the manufacturer.

Device

Commercial Name: Maxillofacial Distraction System Technical Name: Bone Distrator ANVISA Registrat...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH