Events

Rappel de Device Recall Synovis PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement

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 Synovis Surgical Inovation Div. of.

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
    32264
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0891-05
  • Date de mise en oeuvre de l'événement
    2005-05-23
  • Date de publication de l'événement
    2005-06-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-11-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39470
  • 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
    Mesh, Surgical - Product Code FTM
  • Cause
    Device is contained in 2 pouches. the outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile.
  • Action
    The sites and/or distributors that received the suspect devices were contacted by telephone and given instruction how to return/replace the devices. A Recall Notice, dated 05/31/05, was also sent to customers indicating the model number(s) and quantities of affected product which the institution received and the amount they were to return.

Device

Device Recall Synovis PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement
  • Modèle / numéro de série
    Lot Number: 5707464-166925, 5707598-118352, 5708605-151644, 5708622-152524, 5708624-152526, 5709355-167627, 5709825-173142, 5709826-173143 and 5709827-173144
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    AK, AL, AZ, CA, DE, FL, GA, MO, OR, TN, TX, VA and WA
  • Description du dispositif
    Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 ETS-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Produt derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Synovis Surgical Innovations A Division of Synovis Life Technologies, Inc., 6575 University Ave W., St. Paul, MN 55114-1024 USA. 651 796-7300, 800.487.9627
  • Manufacturer
    Synovis Surgical Inovation Div. of

Manufacturer

Synovis Surgical Inovation Div. of
  • Adresse du fabricant
    Synovis Surgical Inovation Div. of, 2575 University Ave W, Saint Paul MN 55114-1073
  • Source
    USFDA