Events

Retiro De Equipo (Recall) de ACTIS Flex Reamers

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 Orthopaedics 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
    75540
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0650-2017
  • Fecha de inicio del evento
    2016-10-25
  • Fecha de publicación del evento
    2016-11-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150760
  • 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
    Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Causa
    Depuy orthopaedics, inc. is issuing a voluntary recall for all lots of the actis flex reamers due to the instruments breaking and potentially leaving pieces in the patient.
  • Acción
    Depuy Orthopaedics initiated a recall on October 25, 2016. Notices were sent to the US Distributors via email on October 25, 2016. Customers were instructed to do the following: 1. Immediately Inspect Inventory, 2. Immediately Return US Distributor Inventory: If any affected instruments are found in a US Distributors inventory, return to: DePuy Synthes Joint Reconstruction, a division of DePuy Orthopaedics, Inc. 3. To expedite the return and credit process: Be sure to reference H16-14 on all return paperwork and/or online return forms and on the outside of the box when returning recalled lots of the instrument. 4. Upon receipt of the affected instruments, affected instruments will be credited against the US Distributors B&R; budget. 5. Within 5-Business Days: Complete the Distributor Card or for the Reconciliation Form: Within 5-business days of initiation, the completed Reconciliation Form should be returned to DePuy Orthopaedics, Inc. 6. Retain copies of all field action documents in customer files For further questions please call (574) 371-4917.

Device

ACTIS Flex Reamers
  • Modelo / Serial
    Product Codes: 201001210, ACTIS FLEX REAMER SZ 0/1, GTIN: 10603295434818; 201001220, ACTIS FLEX REAMER SZ 2/3, GTIN: 10603295434870; 201001230, ACTIS FLEX REAMER SZ 4/5, GTIN: 10603295434849; 201001240, ACTIS FLEX REAMER SZ 6/7, GTIN: 10603295434856; 201001250, ACTIS FLEX REAMER SZ 8/9, GTIN: 10603295434863; 201001260, ACTIS FLEX REAMER SZ 10/11, GTIN: 10603295434825; 201001270, ACTIS FLEX REAMER SZ 12, GTIN: 10603295434832
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to the states of: CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA Foreign: Austria, Ireland, and Japan VA/DOD:
  • Descripción del producto
    ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
  • Manufacturer
    Depuy Orthopaedics Inc.

Manufacturer

Depuy Orthopaedics Inc.
  • Dirección del fabricante
    Depuy Orthopaedics Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA