Events

Rappel de Device Recall PTHYBRID

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, 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
    63850
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0660-2013
  • Date de mise en oeuvre de l'événement
    2012-12-06
  • Date de publication de l'événement
    2013-01-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114932
  • 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, semi-constrained, metal/polymer cemented - Product Code KWS
  • Cause
    Biomet is recalling part number pt-113950 pt hybrid glenoid post, following an investigation which identified that the male thread of the post may be oversized. this oversized condition can vary in degree and may lead to the following three events: 1) if the pt hybrid glenoid post is not fully seated into the hybrid base and the implant construct is implanted, then a gap of 1-3 mm will be prese.
  • Action
    Biomet Inc. sent a Urgent Medical Device Recall Notices dated December 6, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notice identified the reason for the recall including directions to immediately locate, discontinue use of the device. Surgeons were asked to continue monitoring of patients implanted. Customers were asked to confirm receipt of the notice by calling 1-888-348-9500 extension 1570. Customers with product to be returned are asked to obtain RGA # by calling 574-372-6677 . A FAX Back Response Form is to be filled out and sent within 3 days of receipt to 574-372-1683. Biomet, Attention Return Goods, Building B Recalls, 56 East Bell Drive, Warsaw, IN 46580. Questions related to the notice should be directed to 574-371-1570, Monday- Friday 8 a.m. to 5 p.m.

Device

Device Recall PTHYBRID
  • Modèle / numéro de série
    Part 113950 Lot 093540, 093550,093570,093580,093590,093600,093610,093620,093720, 093730,093740,093760,093770,093780,282590,282600,282620,282630, 282680,282700,282710,489160,489180,489200,489210,489770,489780, 489790,714480,714550,714570,714700,714730,722210,722250,722280, 984770,984780,984790,984800,984810,984820,984830,984840, and 984850
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile.
  • Description du dispositif
    PT113950 PT HYBRID Glenoid Post || Regenerex porous titanium construct || Sterile R || Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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