Events

Retiro De Equipo (Recall) de ZNN Nails

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 Biomet, 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
    77141
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2599-2017
  • Fecha de inicio del evento
    2017-04-28
  • 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=155298
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    Zimmer biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
  • Acción
    Zimmer Biomet initiated a voluntary recall for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. Compromised packaging may result in surgical delays, possible infections, and revision surgeries due to infections. The firm distributed letters to customer via FED EX on 04/28/2017. Customers were instructed to do the following: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Note that any hospitals and/or surgeons that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager and Surgeon Recall Notice directly. Additionally, Zimmer Biomet will also notify surgeons that have implanted the affected product within the past 12 months. It is important that you review the list of hospitals and/or surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals and/or surgeons that may have received or used the affected product within the past 12 months. If there are no additional users to notify, please confirm this by annotating and returning the form provided indicating that no additional users have been identified. 5. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet within 2 weeks. a. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. b. Include a

Device

ZNN Nails
  • Modelo / Serial
    510K:K083497, K082770 Item Numbers: 47249146014 47249246014 47249246114 47249538014 47249540014 47249542014 47249544014 Lot Numbers: 61103290 61103290V 61138671 61138682 61138671V 61138682V 61138676 61138687 61138676V 61138687V 61103287 61103287V 61103281 61103283 61103281V 61103283R 61103283V 61180209 112352 61202807 61205842 61202807R 61205842R 61202808 61202808R 61205846 61187350 61187350R 61218276 61218276R 61216615 61223061 61230526 61229396 61229407 61229396R 61229407R 61245120 61245155 61260972 112919 61237017 61263494 61260970 61260970R 61256429 61273711 61187351 61273717 61277263 61187351R 61279018 61289441 61277247 61283862 61283873 112952 112774 61301593 61306420 61301600 61318941 61318947 61314858 61318980 61326405 61326398 61330162 61326398R 61328635 61332013 61328635R 61332013R 61332010 61338025 61353225 61358628 61338029 61358630 61358666 61371216 61370312 61370393 61363474 61363484 61314868 61391745 61471261 61471280 61477302 61550757 7891217 61889853 63246520
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Domestic: Puerto Rico, AK AL AR AZ CA CO CT 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 Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON DELIVERY SERVICE (LYNBROOK NY) MALAYSIA MEXICO MIAMI FL MOROCCO NETHERLANDS NEW ZEALAND NICARAGUA PANAMA PERU PHARR TEXAS POLAND PUERTO RICO RIO DE JANEIRO SAUDI ARABIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND THE NETHERLANDS TRIPOLI UK VIRGIN ISLANDS VA/DOD: Both see addresses below
  • Descripción del producto
    Z NAIL PF 14MM X 46CM UNIV || Z NAIL GT 14MM X 46CM R || Z NAIL GT 14MM X 46CM L || Z NAIL TIBIA 14MM X 38CM UNIV || Z NAIL TIBIA 14MM X 40CM UNIV || Z NAIL TIBIA 14MM X 42CM UNIV || Z NAIL TIBIA 14MM X 44CM UNIV
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, 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