Device Recall Artificial Bur Fascia Prothesis

Lot 54643.2

General and Plastic Surgery Devices

2

Yes

Wordwide Distribution - USA including IL, AZ, PA, CT, MO, WI, NY, TX, OR, ME, FL, VA, and MS and the countries of Mexico and Qatar.

The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound Dressing. || Contents: Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. || Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. || Manufactured For: NOVOMEDICUS, LLC P.O. Box 2105 Nokomis, FL 34274. || Used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.