Events

Rappel de Device Recall Zimmer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Zimmer, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72132
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2820-2015
  • Date de mise en oeuvre de l'événement
    2015-08-27
  • Date de publication de l'événement
    2015-09-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139919
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Guide, surgical, instrument - Product Code FZX
  • Cause
    Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. package testing supports a 5-year expiration date for these same guide wires.
  • Action
    Zimmer sent an "URGENT MEDICAL DEVICE RECALL" notifications dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities: 1.Review the notification and ensure affected personnel are aware of the contents. 2.Locate part number and lot number combinations listed in attachment 1 and quarantine the devices immediately. 3.Carry out a physical count of all affected product in your territory, including hospitals in your territory with direct sales as well as consignment, and complete the Inventory Return Certification of Acknowledgement (Attachment 2). Email a completed copy of Attachment 2 to corporatequality.postmarket@zimmerbiomet.com. 4.Return the recalled product along with the completed Attachment 2. Clearly mark the outside carton of each product return shipment made as Recall. 5.Please notify Zimmer Biomet of any hospitals and surgeons that have consumed the product in the past 12 months that are not included in either the distribution history or inventory system data information. Supply the information for any hospitals and surgeons that you have additionally identified by using the provided spreadsheet Additional Account template. The template, and the list of known consignees from the distribution history and inventory systems data, will be emailed to you for completion and return to: corporatequality.postmarket@zimmerbiomet.com. 6.If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST For further questions about this recall, please call ( 1-800-447-5633).

Device

Device Recall Zimmer
  • Modèle / numéro de série
    00-2228-024-00 2.4MM Diameter Bullet Tip Guide Wire; 00-2255-025-00 Humeral Smooth Guide Wire 2.4mm 70cm Length; 00-2255-026-00 Humeral Bullet Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2237-033-00 Smooth Guide Wire 2.4mm Diameter 100cm Length; 47-2237-037-00 3.0MM Diameter Smooth Guide Wire 100cm Length; 47-2237-038-00 Bullet Tip Guide Wire 3.0mm Diameter 100cm Length; 47-2255-008-00 Ball Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2255-008-01 Ball Tip Guide Wire 3.0mm Diameter 100cm Length All non-expired, distributed lots with a 10 year expiration date on the label.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including Puerto Rico and Virgin Islands., and to the countries of Canada, Brazil, Algeria, Mexico, Austria, Taiwan, Belgium, Hong Kong, Croatia, Singapore, Denmark, Bahamas, Egypt, Panama, Finland, Dominican Republic, France, Guatemala, Germany, Australia, Ireland, Japan,Italy, Haiti, Jordan, Malaysia, Kenya, India, Lebanon, Luxembourg, Malta, Mauritius, Morocco, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom and United Arab Emirates.
  • Description du dispositif
    Zimmer Guide Wires for orthopedic procedures.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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