Rappel de Device Recall Straumann Emdogain

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 Straumann Manufacturing, 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
    79738
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1693-2018
  • Date de mise en oeuvre de l'événement
    2018-03-23
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Biologic material, dental - Product Code NQA
  • Cause
    A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
  • Action
    Customer notification letters were distributed 3/23/18. Action to be taken: 1. Check your inventory for the above listed article and lot numbers and return all unused/unpackaged Emdogain using the enclosed prepaid UPS label as indicated on the Customer Confirmation Form. Your account will be credited upon receipt. 2. If you have already unpacked the Emdogain from the outer box, the lot number on the blister package will be different. Please check your Emdogain for the syringe blister lot numbers listed above and return them for credit using the enclosed prepaid UPS label as indicated on the Customer Confirmation Form. 3. If you have already used the Emdogain with the above listed article and lot numbers, please document receipt of this Field Safety Notice in the applicable patient files. Complete and return the enclosed Customer Confirmation Form via fax to the number listed on the form. Please also report the outcome of the surgical treatment with this product on the enclosed Customer Treatment Outcome Form and fax the form to the number listed on the form. 4. For all cases complete and return the enclosed Customer Confirmation Form and return to Straumann using the enclosed UPS label (if returning product) or via fax (if notifying us the product has already been used). This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. Updated Notification letters including an additional lot number were distributed beginning 4/18/18.

Device

  • Modèle / numéro de série
    Lot NP737, Syringe Blister Lot NA438A, Exp 3/31/2019; Lot PG628, Syringe Blister Lot NF819A, Exp 3/31/2019; Lot PY816, Syringe Blister Lot PT888C, Exp 1/31/2020; Lot NY939, Syringe Blister Lot, NA438A, Exp 3/31/2019
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed US Nationwide and Puerto Rico.
  • Description du dispositif
    Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Straumann Manufacturing, Inc., 60 Minuteman Rd, Andover MA 01810-1008
  • Société-mère du fabricant (2017)
  • Source
    USFDA