Devices

Device Recall OPTEFORM Allograft Paste

  • Modèle / numéro de série
    Serial Numbers: 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458 and 8504459.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed to Florida.
  • Description du dispositif
    ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.
  • Manufacturer
    RTI Surgical, Inc.
  • 1 Event

Fabricant

RTI Surgical, Inc.
  • Adresse du fabricant
    RTI Surgical, Inc., 11621 Research Cir, Alachua FL 32615-6825
  • Société-mère du fabricant (2017)
    RTI Surgical Inc
  • Source
    USFDA