Events

Rappel de Thinflap System Case

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 Biomet Microfixation, LLC.

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
    72366
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0137-2016
  • Date de mise en oeuvre de l'événement
    2015-08-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-10-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140803
  • 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
    Plate, cranioplasty, preformed, alterable - Product Code GWO
  • Cause
    The lids on implant caddies within p/n 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
  • Action
    Biomet Microfixation made phone calls on August 6, 2015 and an initial notice letter sent via FedEx on August 6, 2015, to all distributors. During the phone conversation the distributors confirmed that the inventory invoiced to them is currently in their possession and were asked to remove the lids from the trays and return them back to Biomet Microfixation. In conjunction to the Initial Notice, replacement lids were sent to their business address. Follow¿up communication would be distributed until all units are returned to Biomet Microfixation. Distributors were instructed to do the following: 1. Immediately locate and remove from circulation the items invoiced to your account as identified on this notice. 2. Remove the lids from the quarantined units and replace with the lids (15-5001-18 or 19-5001-18) received with this Initial Notice. The new lids are being distributed to address the issue with the trays. 3. Return the lids removed from the quarantined units to Zimmer Biomet CMF and Thoracic team with the labeling information provided with this notice. RETURN THIS LID: lot number(101337 or 101~65) located on the back of the lid DO NOT RETURN NEW LID: Part numbert 15-5001-18 or 1~5001-18 respectively 4. Use the FedEx label in this packet to return the lids; this will be Zimmer Biomet's method of tracking your return. If distributors have further distributed this product, they must notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field safety notices. Please understand it is your responsibility to locate and quarantine these products. Customers with questions were instructed to call at 1-800-874-7711 or 904-741-4400, extension 9574, Monday through Friday, 8am-4pm ET.

Device

Thinflap System Case
  • Modèle / numéro de série
    Lot Code # 101465 Model # 19-5000
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
  • Description du dispositif
    Thinflap System Case || The cases hold surgical instrumentation in place during handling and storage.
  • Manufacturer
    Biomet Microfixation, LLC

Manufacturer

Biomet Microfixation, LLC
  • Adresse du fabricant
    Biomet Microfixation, LLC, 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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