• Can be used for acute and chronic wounds, diabetic ulcers, pressure injuries, surgical wounds, burns, and venous ulcers
• Flexible, conforming cover that naturally adheres to complex anatomies and may be used over exposed bone, tendon, joint capsule, muscle, and hardware
• Designed for application directly to acute and chronic wounds
• Immune neutral
• No need for sutures or Steri-Strips®
• Available in multiple sizes to reduce wastage
GRAFIX PL* is limited to the homologous use as a wound cover/wrap/barrier.
There are no known contraindications for this product.
Intended for use in one patient, on a single occasion only.
Do not use if package integrity has been compromised. Once the user breaks the seal on the pouch, GRAFIX PL* must be transplanted or discarded.
GRAFIX PL* may not be sterilized.
GRAFIX PL* is intended for use by qualified health care specialists such as physicians, podiatrists, or other appropriate health care professionals.
The same medical/surgical conditions or complications that apply to any medical/surgical procedure may occur during or following application.
The health care professional is responsible for informing the patient of the risks associated with his/her treatment and the possibility of complications or adverse reactions.
Caution should be exercised for patients with known sensitivities for reagents used for processing, disinfection and storage which may remain on the product.
Donor screening methods are limited; therefore, certain diseases may not be detected. The following complications of tissue transplantation may occur:
• Transmission of infectious agents or diseases of known or unknown etiology including, but not limited to, fungi, bacteria, or viruses;
• Immune rejection of implanted GRAFIX PL*; or
• Loss of function and/or integrity of GRAFIX PL*.
GRAFIX PL* should be stored at room temperature prior to application. Refer to the expiry date on the labeled package.
GRAFIX PL* can be applied in an office, hospital outpatient setting or in an operating room. Proper aseptic technique should be followed when applying the product. GRAFIX PL* naturally conforms to complex anatomies and may be used over exposed bone, tendon, joint capsule, and muscle. GRAFIX PL* may be used to repair acute and chronic wounds, encompassing both upper extremity and lower extremity, including but not limited to: diabetic foot ulcers, venous leg ulcers, pressure injuries, dehisced surgical wounds, burns, acute surgical wounds, pyoderma gangrenosum and epidermolysis bullosa.
Reapply weekly at the discretion of the responsible physician for the duration of the treatment of the patient's wound.
Cover the applied graft in the wound with a non-adherent dressing followed by saline moistened gauze to fill but not pack the wound, or use another dressing as appropriate for the wound type.
GRAFIX PL* is supplied in sheet form between two (2) mesh applicators and packaged within a heat-sealed pouch contained within a tertiary box. This packaging configuration allows for the introduction of GRAFIX PL* into the sterile field.
Except as otherwise expressly provided herein, Smith & Nephew, Inc. and its affiliates make no warranties or representations, express, or implied, and to the extent permitted by law. The implied warranties or fitness for a particular purpose and merchantability are specifically disclaimed.
Donor eligibility is determined based on FDA screening and testing criteria, which includes testing for the following:
Human Immunodeficiency Virus Type 1 Antibody (HIV)
Human Immunodeficiency Virus Type 2 Antibody (HIV)
Hepatitis C Virus Antibody (HCV)
Hepatitis B Surface Antigen (HBV)
Hepatitis B Core Antibody (HBV)
Syphilis Rapid Plasma Reagin or Treponemal Specific Assay
Human T-Cell Lymphotropic Virus Type I Antibody (HTLV)
Human T-Cell Lymphotropic Virus Type II Antibody (HTLV)
HIV/HCV/HBV Nucleic Acid Test (NAT)
West Nile Virus (WNV) Nucleic Acid Test (NAT)
Each lot much be sterility negative per USP <71>
Presence of growth factors and viable cells across ≥ 70% of the tissue tested.
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