Events

Safety Alert for (1) Cancellous, (2) Cardiovascular, (3) Demineralized Ground Cortical, (4) Fascia Can, (5) Femoral Heads, (6) Femoral Shafts, (7) Fibulas, Humeral Heads, (9) Iliac Crest Wedges, (10) Ilium Strips, (11) Nondemineralized Ground Cortical, (12) Patellar Ligaments, (13) Patellar Wedges, (14) Pericardium, (15) Pulmonary Patch Grafts, Vertigrafts. US-ID: 98-0206-001, 98-0206-002, 98-0206-004 to 98-0206-006, 98-0206-010 to 98-0206-017, 98-0206-030 to 98-0206- 034, 98-0385-001 to 98-0385-010, 98-0385-014 to 98-0385-029, 98-0385B-008 to 98-0385B-062, 98-0385B-065 to 98-0385B-209, 98-0476-001 to 98-0476-008, 98-0476-010 to 98-0476-029, 98-0476B-013 to 98-0476B-109, 98-0476B-112 to 98-0476B-238, 98- 0476B-240 to 98-0476B-250, 98-1517-001 to 98-1517-006, 98-1517-010, 98-1517-011, 98-1517-013 to 98-1517-018, 98-1517- 024 to 98-1517-027, 98-1517-029 to 98-1517-045, 98-1517B-003 V 98-1517B-092, 98-1517B-098 to 98-1517B-177, 99-0237-001 to 99-0237-013, 99-0237-016 to 99-0237-022, 99-0237-028, 99-0237-029, 99-0237-032, 99-0237-034 to 99-0237-038, 0237-041 to 99-0237-057, 99-0522-001 to 99-0522-014, 99-1630-001 to 99-1630-005, 99-1630-016 to 99-1630-018;

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by LifeNet.

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
    387
  • Date
    2002-02-15
  • 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 above tissues may have been collected from donors who were not properly evaluated. the manufacturer initiated a correction by letter dated october 16, 2001.
  • Action
    Make sure you have received the letter dated October 16, 2001 from LifeNet. Identify and isolate any affected product in your inventory. For more information, contact LifeNet by phone at (1757) 464-4761 within the US or your local representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

(1) Cancellous, (2) Cardiovascular, (3) Demineralized Ground Cortical, (4) Fascia Can, (5) Femora...
  • Model / Serial
  • Manufacturer
    LifeNet

Manufacturer

LifeNet
  • Source
    ANVSANVISA