Events

Recall of Device Recall Strattice Reconstructuve 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
    56261
  • Event Risk Class
    Class 3
  • Event Number
    Z-2623-2010
  • Event Initiated Date
    2010-07-12
  • Event Date Posted
    2010-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93085
  • 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
    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
  • Model / Serial
    Lot S10624, Exp. 2011-04.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    LifeCell Corporation, 1 Millennium Way, Somerville NJ 08876-3876
  • Manufacturer Parent Company (2017)
    Allergan Public Limited Company
  • Source
    USFDA