Events

Retiro De Equipo (Recall) de Device Recall Sharpoint 40 Nylon Suture

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 Surgical Specialties Corp.

¿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
    58449
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2138-2011
  • Fecha de inicio del evento
    2011-03-30
  • Fecha de publicación del evento
    2011-05-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99373
  • 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
    Suture, Cardiovascular - Product Code DTH
  • Causa
    Mislabeled - a number of units of the product labeled as 4-0 black mono nylon suture product contain a 4-0 black braided silk suture.
  • Acción
    Surgical Specialites sent an Urgent Product Recall Notification letter on March 30, 2011, along with an attached Customer Acknowledgment Form to the affected consignees. It was reported that upon opening a box labeled as 4.0 Black Mono Nylon, it was observed that the package acutally contained 4-0 Black Braided Silk suture. Customers were to review their current inventory, segregate the affected lot number and / or contact their customer accounts that have purchased this specific item / lot code requesting a return of the product to customers' facility. To ensure customers have received this notification and to arrange for credit and the return of identified product, the Customer Acknowledgment Form should be completed and returned via fax to our Quality Assurance department at (610) 404-8488.

Device

Device Recall Sharpoint 40 Nylon Suture
  • Modelo / Serial
    Product Code - AC-0584D, lot number M446840
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Class 3 Recall - Worldwide Distribution-- USA and Australia.
  • Descripción del producto
    SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. || Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures.
  • Manufacturer
    Surgical Specialties Corp

Manufacturer

Surgical Specialties Corp
  • Dirección del fabricante
    Surgical Specialties Corp, 100 Dennis Dr, Reading PA 19606
  • Empresa matriz del fabricante (2017)
    Angiotech Pharmaceuticals, Inc.
  • Source
    USFDA