Events

Retiro De Equipo (Recall) de Device Recall 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile

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 (USA) Products LLC.

¿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
    79157
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0902-2018
  • Fecha de inicio del evento
    2017-07-26
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161454
  • 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
    Reamer - Product Code HTO
  • Causa
    Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
  • Acción
    The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 7/26/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following: If you DO have any of the identified devices and intend to re-sterilize the product (TRAUMA Products only) per the package insert, please take the following steps: ¿ Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located and will be re-sterilized. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided. ¿ Send a copy of the completed Verification Section to Synthes by: o Fax: 844-721-3045 or o Scan/email: Synthes5735@stericycle.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification. If you DO have any of the identified devices, and are returning the product for replacement, 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 4 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 4 of this letter) with the product to: o Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. ¿ Send a copy of the completed Verification Section to Synthes by: o Fax: 844-721-3045 or o Scan/email: Synthes5735@stericycle.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clea

Device

Device Recall 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile
  • Modelo / Serial
    Distributed 17-Apr-2017 to 8-June-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H040501 7/29/2016 2025-06-30 H105498 8/5/2016 2026-02-28 H213824 10/27/2016 2025-09-30
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.
  • Descripción del producto
    2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S || Reaming Rods are intended for guiding of reamers during orthopedic surgery.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Dirección del fabricante
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA