Events

Rappel de Device Recall GalaSHAPE 3D

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 Tepha Incorporated.

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
    75827
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0948-2017
  • Date de mise en oeuvre de l'événement
    2016-11-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151792
  • 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
    surgical film - Product Code OOD
  • Cause
    Endotoxin values from testing of retains slightly exceeded the established specification.
  • Action
    Tepha Medical Devices sent a Voluntary Product Recall Notification letter dated November 22, 2016, to all affected customers. Beginning on 11/21/2016, all impacted customers were notified of the recall via phone or in person by Galatea Surgical, a wholly owned subsidiary of Tepha, responsible for the sales and marketing of GalaSHAPE 3D. That notification was followed up by the Tepha recall letter dated November 22, 2016, delivered by certified mail. Customers were instructed to do the following: 1) Immediately review your inventory for the affected lot number listed above. 2) If you do not have any of the affected lot in your inventory, complete the enclosed Recall Acknowledgment Form, indicate that you have zero (O) inventory and fax the completed form back to (781) 357-1701 or email it to contact@galateasurgical.com. 3) If you do have inventory from the affected lot, please complete the enclosed Recall Acknowledgement Form and fax back to Tepha, Inc. at (781) 357-1701 or email it to contact@galateasurgical.com. A Galatea representative will contact you to arrange for the product return. If you have any questions or require assistance with the return of the recalled product, please call Galatea Surgical, at (781) 357-1752. For questions regarding this recall call 781-357-1750.

Device

Device Recall GalaSHAPE 3D
  • Modèle / numéro de série
    Lot Number: 160294
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to IN, CA, FL, MI, NV, and MT
  • Description du dispositif
    GalaSHAPE 3D; product code SH3D03, a medium size oval || GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
  • Manufacturer
    Tepha Incorporated

Manufacturer

Tepha Incorporated
  • Adresse du fabricant
    Tepha Incorporated, 99 Hayden Ave Ste 360, Lexington MA 02421-7966
  • Société-mère du fabricant (2017)
    Tepha Inc.
  • Source
    USFDA