Events

Rappel de Device Recall CollaGuide Collagen Dental Membrane

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 Kensey Nash Corp.

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
    61819
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1621-2012
  • Date de mise en oeuvre de l'événement
    2012-02-28
  • Date de publication de l'événement
    2012-05-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109171
  • 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
    Barrier, animal source, intraoral - Product Code NPL
  • Cause
    Recall has been initiated due to concerns regarding the sterility of the product. the firm initiated the recall because of use of inadequately sterilized product might result in patient infection,.
  • Action
    Reimser, Inc. sent an "URGENT PRODUCT RECALL-COLLAGUIDE COLLAGEN DENTAL MEMBRANE" letter dated March 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to cease use, secure and quarantine affect product. Additionally, a Recall Acknowledgement Form was attached for customers to complete and return to the firm via fax to 1-800-505-4982. Contact the firm at 484-713-2197 for questions regarding this recall.

Device

Device Recall CollaGuide Collagen Dental Membrane
  • Modèle / numéro de série
    15mm X 20mm Part Number 20650-01 Lot # 88519 Expiration date 03/31/12  Lot # 92008 Expiration date 09/30/12 Lot # 92067 Expiration date 09/30/12 Lot # 92338 Expiration date 10/31/12 Lot # 94764 Expiration date 03/31/13 Lot # 95275 Expiration date 05/31/13 Lot # 95910 Expiration date 05/31/13 Lot # 97039 Expiration date 08/31/13 Lot # 98318 Expiration date 11/30/13 Lot # 98343 Expiration date 12/31/13 Lot # 84504 Expired Lot # 85270 Expired Lot # 88165 Expired
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. || Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only || 15mm X 20mm || Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use. || CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
  • Manufacturer
    Kensey Nash Corp

Manufacturer

Kensey Nash Corp
  • Adresse du fabricant
    Kensey Nash Corp, 735 Pennsylvania Dr, Exton PA 19341
  • Société-mère du fabricant (2017)
    Royal DSM NV
  • Source
    USFDA