Device Recall FormPutty Bone Void Filler 10cc

  • Modèle / numéro de série
    Lot # A08F01E Exp Date 2010-06
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution --- including states of FL, OH, TX, and UT.
  • Description du dispositif
    FormPutty Bone Void Filler 10cc || The product is sealed in a foil pouch and then placed in a box following sterilization. || Part # 50-07-0100 || Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Theken Spine LLC, 1800 Triplett Blvd, Akron OH 44306-3311
  • Société-mère du fabricant (2017)
  • Source
    USFDA