Events

Rappel de Zimmer M/DN Intramedullary Fixation Metaphyseal/Diaphyseal Nail System

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
    71243
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1694-2015
  • Date de mise en oeuvre de l'événement
    2015-04-29
  • Date de publication de l'événement
    2015-05-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136987
  • 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
    Screw, fixation, bone, non-spinal, metallic - Product Code NDJ
  • Cause
    The entire scope of 4.5mm cortical screws listed as compatible with the m/dn system is not compatible with the m/dn system. this has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of the screw after fracture healing.
  • Action
    Zimmer sent an Urgent Medical Device Recall letter dated April, 29, 2015, to all affected customers.On 4/29/2015. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate all affected product and quarantine them immediately. Return the recalled product along with completed Inventory Return Certification Form. Notify Zimmer of any further distribution of the affected product. In addition, identify the surgeons and hospitals that you have identified using the provided spreadsheet. For further questions call the customer call center at 1-877-946-2761.

Device

Zimmer M/DN Intramedullary Fixation Metaphyseal/Diaphyseal Nail System
  • Modèle / numéro de série
    All lots. Part numbers: 00-2253-020-45  INTERLOCKING IM SCREW 4.5MM DIA X 20MM 00-2253-022-45  INTERLOCKING IM SCREW 4.5MM DIA X 22.5MM 00-2253-025-45  INTERLOCKING IM SCREW 4.5MM DIA X 25MM 00-2253-027-45  M/DN Intramedullary Fixation 4.5mm Dia. Cortical Screw 00-2253-030-45 INTERLOCKING IM SCREW 4.5MM DIA X 30MM 00-2253-032-45  INTERLOCKING IM SCREW 4.5MM DIA X 32.5MM 00-2253-035-45 INTERLOCKING IM SCREW 4.5MM DIA X 35MM 00-2253-037-45 INTERLOCKING IM SCREW 4.5MM DIA X 37.5MM 00-2253-040-45 INTERLOCKING IM SCREW 4.5MM DIA X 40MM 00-2253-042-45  INTERLOCKING IM SCREW 4.5MM DIA X 42.5MM 00-2253-045-45  INTERLOCKING IM SCREW 4.5MM DIA X 45MM 00-2253-047-45  INTERLOCKING IM SCREW 4.5MM DIA X 47.5MM 00-2253-050-45  INTERLOCKING IM SCREW 4.5MM DIA X 50MM 00-2253-052-45  INTERLOCKING IM SCREW 4.5MM DIA X 52.5MM 00-2253-055-45 INTERLOCKING IM SCREW 4.5MM DIA X 55MM 00-2253-057-45 INTERLOCKING IM SCREW 4.5MM DIA X 57.5MM 00-2253-060-45  INTERLOCKING IM SCREW 4.5MM DIA X 60MM 00-2253-062-45 INTERLOCKING IM SCREW 4.5MM DIA X 62.5MM 00-2253-065-45 INTERLOCKING IM SCREW 4.5MM DIA X 65MM 00-2253-067-45  INTERLOCKING IM SCREW 4.5MM DIA X 67.5MM 00-2253-070-45 INTERLOCKING IM SCREW 4.5MM DIA X 70MM 00-2253-072-45  INTERLOCKING IM SCREW 4.5MM DIA X 72.5MM 00-2253-075-45  INTERLOCKING IM SCREW 4.5MM DIA X 75MM 00-2253-077-45  INTERLOCKING IM SCREW 4.5MM DIA X 77.5MM 00-2253-080-45 INTERLOCKING IM SCREW 4.5MM DIA X 80MM 00-2253-082-45 INTERLOCKING IM SCREW 4.5MM DIA X 82.5MM 00-2253-085-45  INTERLOCKING IM SCREW 4.5MM DIA X 85MM 00-2253-087-45  INTERLOCKING IM SCREW 4.5MM DIA X 87.5MM 00-2253-090-45  INTERLOCKING IM SCREW 4.5MM DIA X 90MM
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada, Brazil, Mexico, Bahamas, Nicaragua, Singapore, China, Japan, Malaysia, Taiwan, Thailand, Korea, Spain, Belgium, Switzerland, India, Germany, England, Italy, Saudi Arabia, Lebanon, Libya, United Arab Emirates, Algeria, France, United Kingdom, Canary Islands, Iraq, Jordan, Lithuania, Morocco, Macedonia, Malta, Mauritius, Serbia, Russian Federation, and Yemen.
  • Description du dispositif
    Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
  • 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