Events

Rappel de Device Recall Bigliani/Flatow The Complete Shoulder Solution

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
    65290
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1676-2013
  • Date de mise en oeuvre de l'événement
    2013-06-11
  • Date de publication de l'événement
    2013-07-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118471
  • 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
    Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
  • Cause
    The firm is initiating a removal of one lot of the bigliani/flatow humeral provisional stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.
  • Action
    Zimmer sent an URGENT MEDICAL DEVICE RECALL notification dated June 11, 2013, to all consignees via email and courier describing the affected device and problem and the risks associated with using the affected device. The notifications provided instructions for returning the affected device to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. Any questions or concerns concerning the recall, please call the customer call center at 1-877-946-2761. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer by email at zimmer.per@zimmer.com. For questions regarding this recall call 800-613-6131.

Device

Device Recall Bigliani/Flatow The Complete Shoulder Solution
  • Modèle / numéro de série
    Item 00-4301-012-17; lot 62283991
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including IL and MO.
  • Description du dispositif
    Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm || This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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