Events

Retiro De Equipo (Recall) de Device Recall DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD

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 DePuy Mitek, Inc., a Johnson & Johnson Co..

¿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
    58037
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2211-2011
  • Fecha de inicio del evento
    2011-02-24
  • Fecha de publicación del evento
    2011-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98060
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Causa
    Metal debris in the shaft component of the device.
  • Acción
    DePuy Mitek sent an Urgent Voluntary Product Recall Notification letter dated February 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check their inventory to determine if they have any affected product. Customers were asked to complete the enclosed business reply form and fax it to 508-828-3750 or email to mitekcomplaints@its.jnj.com whether or not they have any of the affected product remaining in their inventory. Customers were asked to utilize the return good authorization number provided by customer service and return all identified product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 For any questions call 1-877-379-4871 or contact DePuy Mitek Customer Service directly at 1-800-382-4682, PROMPT 3.

Device

Device Recall DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD
  • Modelo / Serial
    Lot Numbers:  3450116 3452126 3452666 3453955 3455280 3455577 3456000 3456320 3457346 3459759 3462333 3463328 3463735 3464069 3473282 3474524 3476556 3478827 3478828 3478166 3496079 3495846
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Austrailia Austria Belgium Canada China Estonia Finland France Germany Great Britain Indonesia Ireland Italy Japan Lebanon Lithuania Netherlands Poland Singapore Slovenia South Africa Spain Sweden and Switzerland
  • Descripción del producto
    DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD || Product Code: 210814 || Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • Dirección del fabricante
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Dr, Raynham MA 02767
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA