Events

Rappel de Synthes

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 Synthes, 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
    68190
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1669-2014
  • Date de mise en oeuvre de l'événement
    2014-04-29
  • Date de publication de l'événement
    2014-05-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127119
  • 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
    Bit, surgical - Product Code GFG
  • Cause
    Certain lots of the prodisc-c 2.0mm milling bits have an increased potential to break during use.
  • Action
    DePuy Synthes sent a Recall letter, dated April 29, 2014, to affected customers. The letter identified the affected customers, problem and actions to be taken. The letter instructed customers to discontinue use and distribution of the device and to return affected devices to Synthes. For questions call 610-719-5450.

Device

Synthes
  • Modèle / numéro de série
    part number: 03.820.161s, with lot numbers: 5742507,5755970,5755971,5755972, 5755973,5755974,5828298,6336115, 6338099,6338100,6340029,6340030, 6344199,6344200,6363601,6385892, 6407046,6431260,6431261,6460402, 6503360,6526127,6571070,6571073, 6571074,6601985,6636946,6636947, 6636948,6653819,6653820,6670383, 6691341,6691342,6718933,6718934, 6718935,6740611,6794651,6794652, 6794653,6794654,6794655  part number: 03.820.1638 with lot numbers: 5742506,5755978,5755979,5755980, 5755981,5755982,5828299,5828300, 6320586,6336108,6336110,6336111, 6340033,6344201,6344202,6363602, 6385893,6431262,6431263,6460403, 6503361,6571075,6601986,6601987, 6636949,6636950,6636951,6653810, 6653818,6670382,6691343,6691344, 6718938,6740615,6740616,6745821, 6770474,6770475,6770476,6770477, 6770478,6794657,6794658  part number: 03.820.167S with lot numbers:  5755983,5755984,5755987,5755988, 5755989,5755985,5755986,5755990, 5828302,6338101,6338102,6338103, 6338104,6338106,6338107,6338108, 6338109,6344205,6471089,6670381, 6718939,6718940,6718941,6843907, 6843906,6856252,6856253,6867662, 6867661,6901712,6901713,6919726, 6919727,6919728,6901710,6901711, 6921717,6921718,6940357,6960192, 6960193,6983033,7006496,7055427  part number: 03.820.169S with lot numbers: 6066520,6113671,6113633,6159883, 6180175,6338068,6338098,6344206, 6363603,6407047,6431264,6460404, 6526128,6571078,6670384,6745820, 6770479,6770480
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Adresse du fabricant
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA