Device Recall Strattice Reconstructuve Tissue Matrix for Stoma Reinforcement

  • Model / Serial
    Lot S10624, Exp. 2011-04.
  • Product Classification
  • 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    LifeCell Corporation, 1 Millennium Way, Somerville NJ 08876-3876
  • Manufacturer Parent Company (2017)
  • Source
    USFDA