Events

Rappel de Device Recall ConMed Hip Preservation System Signature Series

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 ConMed Corporation.

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
    73123
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1842-2016
  • Date de mise en oeuvre de l'événement
    2015-12-21
  • Date de publication de l'événement
    2016-05-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143103
  • 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
    Bur, surgical, general & plastic surgery - Product Code GFF
  • Cause
    Metal shavings released from burs during use are due to contact between the bur and the hood of the prebent bur assembly. during the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings.
  • Action
    ConMed sent an Urgent Medical Device Recall Notification letter dated December 17, 2015, to all affected customers. Customers are urged to stop use and return these devices immediately. Customers who have further distributed these items are urged to contact all of those organizations immediately and provide a copy of the recall notification letter. It is imperative that all end users of these devices receive the recall notice and respond immediately. Customers with questions can call 315-624-3237 or email largohpshb@conmed.com. The devices should be returned to ConMed Corporation NCR-47057 11155 Concept Blvd. Largo, FL 33773. For questions regarding this recall call 315- 624-3533.

Device

Device Recall ConMed Hip Preservation System Signature Series
  • Modèle / numéro de série
    Lot Numbers: 1) 569449, 577583, 577969, 579655, 580365, 581176, 581198, 582216, 587320, 594569, 658219, 669615, 673913 & 688136; 2) 569462, 577800, 577971 & 579652; 3) 569468, 577835, 577974, 579650, 583736, 583742, 587514, 627923, 659317 & 664751.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA; International: Canada, Wales
  • Description du dispositif
    Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 || The ConMed Hip Preservation System Signature Series is intended to be used for resection of osseous tissue (bone) in arthroscopic and endoscopic surgical procedures
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Adresse du fabricant
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    USFDA