Events

Retiro De Equipo (Recall) de Device Recall Zimmer Oscillating Flat

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 Synvasive Technology 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
    72811
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0466-2016
  • Fecha de inicio del evento
    2015-12-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142288
  • 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
    Blade, saw, general & plastic surgery, surgical - Product Code GFA
  • Causa
    Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
  • Acción
    Zimmer sent an Urgent Medical Device Removal letter on December 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: I. Review this notification. 2. You will receive copies of notification sent directly to hospital risk managers and surgeons in your territory. As necessary, review and facilitate understanding of this notification by those entities. 3. Further identify hospital risk managers and/or surgeons in your territory who should also receive notification of this update, and supply the information to the entities you have identified. 4. If after reviewing this notification you have further questions or concerns, please call 330-364-0989 between the hours of 8 a.m. and 5 p.m. EST, Monday through Friday. Letters to Rick Managers are similar and the actions requested by them are: 1. Reviewing this notification and forwarding to all people within your organization that may utilize this product. 2. Identifying and quarantining the affected product to prevent further distribution or use. 3. Completing the attached Response Form and returning it via e-mail to CorporateQua1ity.PostMarket@zimmerbiomet.com. Returning affected product to: Zimmer Surgical Attn: QA!RA Dept. - Recall Please include a copy of the Response Form with the shipment. 4. Upon receipt of affected product, Zimmer will credit your account for unused Zimmer Oscillating Flat Blade - TS ST Hub, 75mm x 19mm, xl.OO/l.27mm, lots 43054 and 45104 only. Please return a copy of the completed response form along with your returned product to ensure proper credit. Important: Please distribute this notification to all personnel within your organization who need to be aware. If you have further distributed affected product(s), please provide the customer 's information on the Business Response Form to Zimmer. Letters also included a FAQ sheet regarding the labeling error.

Device

Device Recall Zimmer Oscillating Flat
  • Modelo / Serial
    Synvasive Part number: 11-4770; Part number: 19075127YT1;  Lot numbers: 45104 and 43054.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to one location each in CT, MA and CA.
  • Descripción del producto
    Zimmer Oscillating Flat - TS ST Hub; || 75mm x 19mm x 1.00/1.27mm; || Synvasive Part No. 11-4770: || Part No. 19075127YT1; || Lot No. 45104 and 43054 || Description: STRYK_76542K_19X75X1.27T || General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures
  • Manufacturer
    Synvasive Technology Inc

Manufacturer

Synvasive Technology Inc
  • Dirección del fabricante
    Synvasive Technology Inc, 4925 Robert J Mathews Pkwy, El Dorado Hills CA 95762-5701
  • 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