Events

Rappel de Device Recall Strattice Reconstructive 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
    60104
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0178-2012
  • Date de mise en oeuvre de l'événement
    2011-07-13
  • Date de publication de l'événement
    2011-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104437
  • 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
    The use of strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the us market.
  • Action
    LifeCell began notifying their customers via phone on 7/13/2011. Recall Notice Letters and return response forms, dated July 12, 2011, were sent out on the same day. The letter identified the affected product and informed customers of the reason for the recall. Customers were asked to examine their inventory and quarantine the affected product. If customers have affected product, they were to contact Customer Solutions at 1-866-423-2433 to arrange for return of the product to LifeCell. Also, the attached Recall Notification form should have been completed and returned no later than August 17, 2011. Questions should be directed to Customer Solutions at 1-866-423-2433.

Device

Device Recall Strattice Reconstructive Tissue Matrix for Stoma Reinforcement
  • Modèle / numéro de série
    The following lots begin with the letter 'S' 10664; 10665; 10666; 10667; 10668; 10670; 10671; 10672; 10678; 10679; 10680; 10683; 10684; 10685; 10686; 10688; 10689; 10690; 10691; 10698; 10700; 10701; 10702; 10777; 10778; 10780; 10838; 10844; 10845; 10847; 10848; 10851; 10863; 10864; 10866; 10867; 10871; 10872; 10875; 10877; 10896; and 10910.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement || Catalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 cm), (0610008 ( 6 cm x 10 cm). || Intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
  • Manufacturer
    LifeCell Corporation

Manufacturer

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