Indications, Safety, and Warnings Grafton™ DBF Inject

GRAFTON™ DBF INJECT

INDICATIONS FOR USE

Grafton™ DBF can be used in orthopedic or reconstructive bone grafting procedures. The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. 

CONTRAINDICATIONS 

The presence of infection at the implantation site is a contraindication for the use of this allograft. 

CAUTION

This allograft may contain trace amounts of antibiotics (gentamicin), antiseptic (povidone-iodine) and alcohol solutions. Caution should be exercised if the patient is allergic to these antibiotics or chemicals. 

ACCESSORY KIT

INTENDED USE

The Graft Preparation and Delivery Device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft materials to an orthopaedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

WARNINGS/PRECAUTIONS

There are no specific warnings, precautions, or adverse effects associated with the use of this device.