Device Recall FormPutty Bone Void Filler 10cc

  • Model / Serial
    Lot # A08F01E Exp Date 2010-06
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of FL, OH, TX, and UT.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Theken Spine LLC, 1800 Triplett Blvd, Akron OH 44306-3311
  • Manufacturer Parent Company (2017)
  • Source
    USFDA