Events

Recall of Device Recall Strattice Reconstructive Tissue Matrix for Stoma Reinforcement

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LifeCell Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60104
  • Event Risk Class
    Class 2
  • Event Number
    Z-0178-2012
  • Event Initiated Date
    2011-07-13
  • Event Date Posted
    2011-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104437
  • Notes / Alerts
    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.
  • Extra notes in the data
    Mesh, surgical - Product Code FTM
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Manufacturer Address
    LifeCell Corporation, 1 Millennium Way, Branchburg NJ 08876-3876
  • Manufacturer Parent Company (2017)
    Allergan Public Limited Company
  • Source
    USFDA