FDA-Device2014-07-23Class II
Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.
PIONEER SURGICAL TECHNOLOGY, INC.
Hazard
Lack of Sterility Assurance
Sold states
US Nationwide Distribution in the states of TX and FL
Affected count
5
Manufactured in
375 River Park Cir, N/A, Marquette, MI, United States
Products
Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2076-2014Don't want to check this manually?
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