Device Recall DuraGen Suturable DuraGen Dural Regenerative Matrix

  • Model / Serial
    1125682, 1125681 1125817, 1125983, 1126018 1126019, 1130641 1130642, 1110848, 1110849 1111883, 1111354, 1111884 1111936, 1112151 1110256, 1111355
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
  • Product Description
    Suturable DuraGen Dural Regenerative Matrix || Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.
  • Manufacturer
  • 1 Event

Manufacturer