Events

Rappel de Device Recall Strattice Reconstructuve Tissue Matrix for Stoma 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 LifeCell 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
    56261
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2623-2010
  • Date de mise en oeuvre de l'événement
    2010-07-12
  • Date de publication de l'événement
    2010-09-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93085
  • 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
    Mislabeled -one lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template.
  • Action
    LifeCell issued Recall Notice letters dated July 12, 2010 to customers, identifying the affected product, the labeling issue, and actions to be taken by the customer. Two versions of the recall notification were sent, one for implanted units and one for those not yet implanted. Both letters stated that the mislabeling has no impact of the safety or effectiveness of the medical device. Replacement units were offered for all affected units. Those with unused units were to contact LifeCell Customer Solutions for return and replacement of the unit at 1-866-423-2433. Those with implanted units may contact LifeCell Customer Solutions at 1-866-423-2433 with any additional questions or concerns.

Device

Device Recall Strattice Reconstructuve Tissue Matrix for Stoma Reinforcement
  • Modèle / numéro de série
    Lot S10624, Exp. 2011-04.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution: USA, including the states of AZ, DC, FL, GA, ID, IL, KY, LA, MO, NC, OH, OK, OR, TX, WA, and WI.
  • Description du dispositif
    Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. || 8 cm x 8 cm || Packaged in an inner foil pouch inside outer foil pouch tertiary carton. || LifeCell Corporation, One Millennium Way, Branchburg, NJ 08876 || Strattice is intended for use as a foil tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is used for repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. It is intended for single patient one time use.
  • Manufacturer
    LifeCell Corporation

Manufacturer

LifeCell Corporation
  • Adresse du fabricant
    LifeCell Corporation, 1 Millennium Way, Somerville NJ 08876-3876
  • Société-mère du fabricant (2017)
    Allergan Public Limited Company
  • Source
    USFDA