Events

Retiro De Equipo (Recall) de Device Recall Trauma Large Screws

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 Zimmer, 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
    68818
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2549-2014
  • Fecha de inicio del evento
    2014-07-22
  • Fecha de publicación del evento
    2014-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129073
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
  • Acción
    Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.

Device

Device Recall Trauma Large Screws
  • Modelo / Serial
    Item Numbers 00114610099, 00114610500, 00114610532, 00114610599, 00114611000, 00114611032, 00114611099, 00114611500, 00114611532, 00114611599, 00114612000, 00114612032, 00114612099, 00114612500, 00114612599, 00114613000, 00114613099, 00225210555, 00225211055, 00225211555, 00225212055, 00225212555, 00225213055, 00225710565, 00225711065, 47234712005, 47234712400, 47234712440, 47234712500, 47234712600, 47234810535, 47234811035, 47235910055, 47248310560, 47248311060, 47248311560, 47248312060, 47248312560, 47248313060, 47248313560, 47248314060, 47248410560, 47248411060, 47248411560, 47248412060, 47248412560, 47248413060, 47248413560, 47248414060, 47348310560, 47348311060, 47348311560, 47348312060, 47348312560, 47348313060, 47348313560, 47348314060, 47348410560, 47348411060, 47348411560, 47348412060, 47348412560, 47348413060, 47348413560, 47348414060, 47483510500, 47483510501, 47483511000, 47483511001, 47483511500, 47483511501, 47483512000, 47483512001, 47483512500, 47483513000, 47483513500, 47483514000, 47483514500, 47483515000, 47484510501, 47484511001, 47484512001, 47486510500, 47486510501, 47486510502, 47486511000, 47486511001, 47486511002, 47486511502, 47486512002 EXPIRATION DATE PRIOR TO 2024-07
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Trauma Large Screws: || CANN BONE SCREW 7.0MMX100MMLG || CANN BONE SCREW 7.0X105LG || CANN BONE SCREW 7.0X105LG || CANN BONE SCREW 7.0MMX105MMLG || CANN BONE SCREW 7.0X110LG || CANN BONE SCREW 7.0X110LG || CANN BONE SCREW 7.0MMX110MMLG || CANN BONE SCREW 7.0X115LG || CANN BONE SCREW 7.0X115LG || CANN BONE SCREW 7.0MMX115MMLG || CANN BONE SCREW 7.0X120LG || CANN BONE SCREW 7.0X120LG || CANN BONE SCREW 7.0MMX120MMLG || CANN BONE SCREW 7.0X125LG || CANN BONE SCREW 7.0MMX125MMLG || CANN BONE SCREW 7.0X130LG || CANN BONE SCREW 7.0MMX130MMLG || RECON SCR LGE 5.5MMDX105MM || RECON SCR LGE 5.5MMDX110MM || RECON SCR LGE 5.5MMDX115MM || RECON SCR LGE 5.5MMDX120MM || RECON SCR LGE 5.5MMDX125MM || RECON SCR LGE 5.5MMDX130MM || ITST ANTI-ROT SCR 6.5MMDX105MM || ITST ANTI-ROT SCR 6.5MMDX110MM || PERI. SCR 3.5MM X105MML || PERI SCR. 6.5MM X 100MM L || PERI SCR. 6.5MM X 140MM L || PERI SCR. 6.5MM X 100MM L || PERI SCR. 6.5MM X 100MM L || 3.5MM CORT SCR X 105MM SELFTAP || 3.5MM CORT SCR X 110MM SELFTAP || 5.5MM X 100MM CANN LKNG SCREW || Z NAIL 6.0 X 105 CANC SCREW PT || Z NAIL 6.0 X 110 CANC SCREW PT || Z NAIL 6.0 X 115 CANC SCREW PT || Z NAIL 6.0 X 120 CANC SCREW PT || Z NAIL 6.0 X 125 CANC SCREW PT || Z NAIL 6.0 X 130 CANC SCREW PT || Z NAIL 6.0 X 135 CANC SCREW PT || Z NAIL 6.0 X 140 CANC SCREW PT || Z NAIL 6.0 X 105 CANC SCREW FA || Z NAIL 6.0 X 110 CANC SCREW FA || Z NAIL 6.0 X 115 CANC SCREW FA || Z NAIL 6.0 X 120 CANC SCREW FA || Z NAIL 6.0 X 125 CANC SCREW FA || Z NAIL 6.0 X 130 CANC SCREW FA || Z NAIL 6.0 X 135 CANC SCREW FA || Z NAIL 6.0 X 140 CANC SCREW FA || Z NAIL 6.0 X 105 CANC SCREW PT || Z NAIL 6.0 X 110 CANC SCREW PT || Z NAIL 6.0 X 115 CANC SCREW PT || Z NAIL 6.0 X 120 CANC SCREW PT || Z NAIL 6.0 X 125 CANC SCREW PT || Z NAIL 6.0 X 130 CANC SCREW PT || Z NAIL 6.0 X 135 CANC SCREW PT || Z NAIL 6.0 X 140 CANC SCREW PT || Z NAIL 6.0 X 105 CANC SCREW FA || Z NAIL 6.0 X 110 CANC SCREW FA || Z NAIL 6.0 X 115CANC SCREW FA || Z NAIL 6.0 X 120CANC SCREW FA || Z NAIL 6.0 X 125 CANC SCREW FA || Z NAIL 6.0 X 130 CANC SCREW FA || Z NAIL 6.0 X 135 CANC SCREW FA || Z NAIL 6.0 X 140 CANC SCREW FA || 3.5X105 CORT SCR || 3.5 X 105 CORT SCR SELF TAP || 3.5X110 CORT SCR || 3.5 X 110 CORT SCR SELF TAP || 3.5X115 CORT SCR || 3.5 X 115 CORT SCR SELF TAP || 3.5X120 CORT SCR || 3.5 X 120 CORT SCR SELF TAP || 3.5X125 CORT SCR || 3.5X130 CORT SCR || 3.5X135 CORT SCR || 3.5X140 CORT SCR || 3.5X145 CORT SCR || 3.5X150 CORT SCR || 4.5 X 105 CORT SCR SELF TAP || 4.5 X 110 CORT SCR SELF TAP || 4.5 X 120 CORT SCR SELF TAP || 6.5X105 CANC SCR, FULLY THDED || 6.5X105 CANC SCR, 16MM THD || 6.5X105 CANC SCR, 32MM THD || 6.5X110 CANC SCR, FULLY THDED || 6.5X110 CANC SCR, 16MM THD || 6.5X110 CANC SCR, 32MM THD || 6.5X115 CANC SCR, 32MM THD || 6.5X120 CANC SCR, 32MM THD
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA