Device Recall AlloFuse DBM Putty 5cc

  • Model / Serial
    Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution US nationwide, including Michigan and a distributor in Colorado.
  • Product Description
    AlloFuse DBM Putty 5cc, Catalog No. 90038005 || AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    AlloSource, Inc., 6278 S Troy Cir, Centennial CO 80111-6422
  • Manufacturer Parent Company (2017)
  • Source
    USFDA