Events

Retiro De Equipo (Recall) de Device Recall Cannulated Drill Bits

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 Synthes, Inc..

¿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
    71277
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1711-2015
  • Fecha de inicio del evento
    2015-05-13
  • Fecha de publicación del evento
    2015-06-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137214
  • 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
    Bit, drill - Product Code HTW
  • Causa
    Affected parts and lots of the cannulated drill bits have the potential to break during use.
  • Acción
    DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated May 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have any of the identified devices, please take the following steps: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. " Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. " Return the Verification Section (page 3 of this letter) with the product to: " Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. " Send a copy of the completed Verification Section to DePuy Synthes by: " Fax: (888) 943-4893 or " Scan/email: Synthes6230@stericycle.com If you DO NOT have the identified product, please take the following steps: " Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. " Return the documents to DePuy Synthes by: " Fax: (888) 943-4893 or " Scan/email: Synthes6230@stericycle.com " Note: If the Verification Section is answered on behalf of more th An urgent medical device recall notice, dated May 13, 2015, was sent to consignees and sales consultants to in form them of the issue and associated risks. All in receipt of the device were asked to discontinue use and return affected devices along with the response form. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales

Device

Device Recall Cannulated Drill Bits
  • Modelo / Serial
    Part Number  310.65 310.67 310.221  lot numbers  PE00966  PE01000 PE01039 PE01058 PE00959  PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971  PE01059 PE01040
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Canada.
  • Descripción del producto
    3.2 mm Cannulated Drill Bit/ QC 170 mm || 2.7 Cannulated Drill Bit/ QC 160 mm || 2.0 mm Cannulated Drill Bit / QC 150 mm || there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Dirección del fabricante
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA