Devices

Device Recall Origen DBM with Bioactive Glass

  • Model / Serial
    Catalog # NAN109-02, Lot #: 074349P.  Catalog # NAN109-05, Lot #: 073995PA, 077870PB.  Catalog # NAN109-10, Lot #: 071045PB, 071043PA, 070916P.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA.
  • Product Description
    Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: nanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***nanotherapeutics***" || Product is labeled in part - Carton label: "***nanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd. Suite 300 Alachua, FL 32615***Rx Only***ONE EACH***" || NanoFUSE DBM Catalog #: || NAN109-02 (2cc size) || NAN109-05 (5cc size) || NAN109-10(10cc size) || "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." || Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
  • Manufacturer
    Nanotherapeutics, Inc
  • 1 Event

Manufacturer

Nanotherapeutics, Inc
  • Manufacturer Address
    Nanotherapeutics, Inc, 13859 Progress Blvd Ste 300, Alachua FL 32615-9403
  • Manufacturer Parent Company (2017)
    Nanotherapeutics, Inc
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Origen DBM with Bioactive Glass
  • Model / Serial
    Catalog # 22-2002 Lot #: 070281P, 070591P, 073221P, 073434P, 073504P, 073577PA, 073761PA, 073761PB, 074349P, 075075PA, 075128P, 075245PA, 075255P, 075259P, 077870PA, 078093PB, 078268PB.   Catalog # 22-2005 Lot #: 067559PA, 067559PB, 0700869, 070281P, 070546PA, 070546PB, 070552P, 070591P, 070743P, 070884PA, 070884PB, 073221P, 073222P, 073346PB, 073434P, 073496P, 073504P, 074032P, 075075PB, 075259P, 075481P, 075637PA, 075637PB, 075660P, 077642PA, 077870PB, 078048P, 078268PB, 078309PA, 079002PA.   Catalog # 22-2010 Lot #: 060095P, 067484P, 070203P, 070281P, 070512P, 070521P, 070603PA, 070607P, 070629P, 070703P, 070704P, 070755P, 070831P, 070916P, 071043PB, 071045PA, 071053PA, 071053PB, 073221P, 073319PB, 073346PA, 073346PB, 073411PB, 073434P, 073494PA, 073494PB, 073502P, 073590P, 073695P, 073751P, 073828P, 073879P, 075050PA, 075058P, 075167PB, 075230PA, 075230PB, 075245PB, 075338PA, 075338PB, 075492PA, 075629P, 077390P, 077715PA, 077715PB, 077863PA, 078093PA, 078268PA, 078268PB, 078344PB.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA.
  • Product Description
    Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" || Product is labeled in part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID***Expiration***Manufactured for Blackstone Medical, Inc by: Nanotherapeutics, Inc. 13859 Progress Blvd. suite 300 Alachua, FL 32615***Distributed By: Orthofix Inc 1720 Bray Central Drive McKinney, TX 75069***Rx Only***ONE EACH***" || Origen DBM with Bioactive Glass Catalog #: || 22-2002 (2cc size) || 22-2005 (5cc size) || 22-2010 (10cc size) || "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." || Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
  • Manufacturer
    Nanotherapeutics, Inc