Events

Retiro De Equipo (Recall) de Device Recall PriMatrix Dermal Repair Scaffold Instructions for Use (IFU)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por TEI Biosciences.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    78802
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0383-2018
  • Fecha de inicio del evento
    2017-06-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-03-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160543
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Dressing, wound, collagen - Product Code KGN
  • Causa
    During final assembly operation, it was noticed that some of the primatrix instructions for use (ifus) from lot rm1608011 part 520-002v10 contained extra pages and/or missing pages: " 22 ifus contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 ifus were missing pages 27 - 50 " 1 ifu was missing pages 1 - 2 & 75 - 76 " 1 ifu was missing pages 15 - 62 while pages 27  50, 75  76, and 15  62 contain instructions written in a language other than english, pages 1  2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.
  • Acción
    Integra LifeSciences Corporation notified (all U.S.) customers via Letter/Medical Device Correction Field Safety Notice dated June 15, 2017. Letter delivered by courier service, facsimile or email July 15, 2017.

Device

Device Recall PriMatrix Dermal Repair Scaffold Instructions for Use (IFU)
  • Modelo / Serial
    Product Model Number Product Lot Number Product Description Product Model Number Product Lot Number Product Description 607-004-880 1508019 8 x 8 cm 607-005-014 1702023 14mm Disc 607-005-880 1509051 8 x 8 cm 607-005-018 1702024 18mm Disc 607-005-440 1512021 4 x 4 cm 607-005-220 1702025 2 x 2 cm 607-005-812 1512022 8 x 12 cm 607-005-014 1702026 14mm Disc 607-005-440 1603044 4 x 4 cm 607-005-018 1702027 18mm Disc 607-005-660 1606038 6 x 6 cm 607-005-220 1702028 2 x 2 cm 607-001-112 1611044 10 x 12 cm 607-005-014 1702029 14mm Disc 607-001-812 1611045 8 x12 cm 607-005-018 1702030 18mm Disc 607-001-225 1612013 20 x 25 cm 607-005-220 1702031 2 x 2 cm 607-001-009 1612018 0.2 x 26.5 cm 607-005-014 1702032 14mm Disc 607-004-440 1701034 4 x 4 cm 607-005-014 1702033 14mm Disc 607-001-440 1701036 4 x 4 cm 607-005-014 1702034 14mm Disc 607-004-660 1701037 6 x 6 cm 607-005-014 1703007 14mm Disc 607-001-660 1701044 6 x 6 cm 607-005-018 1703008 18mm Disc   The affected lots are manufactured from February 2017 to May 2017.   The affected lots will expire in 2020 to 2021.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    Yes
  • Distribución
    U.S.
  • Descripción del producto
    PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
  • Manufacturer
    TEI Biosciences

Manufacturer

TEI Biosciences