Events

Safety Alert for Titanium Bone Anchor Drivers: (1) With Integrated Nylon Sutures, (2) With Integrated Polypropylene Sutures; Fixers for AxyaLoop 5mm Titanium Bone Screws from the following sets of Shoulder Rotation Tendon Correction Procedures: (3) Arthroscopic, (4) Mini-Open. We. Catalog: (1) 1227; (2) 1221; (3) 1502-3, 1506-3; (4) 1501-3; Lots Nos .: (1) 201990, 201991; (2) 201827, 202049; (3) 202052, 202067, 202138, 202193; (4) 202051, 202066, 202183, 202192

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Axya Medical 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
    688
  • Date
    2003-03-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The rods of the above mentioned fasteners can break and do not fit with the fastener head (anchors). the manufacturer initiated a correction / recall by letter dated october 24, 2002.
  • Action
    Make sure you received the letter from Axya Medical on October 24, 2002. Identify and isolate any affected product in your inventory. For further information, please contact your local Axya representative. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Titanium Bone Anchor Drivers: (1) With Integrated Nylon Sutures, (2) With Integrated Polypropylen...

Manufacturer

Axya Medical Inc
  • Source
    ANVSANVISA