Home / Recalls / Medical Devices
PIONEER SURGICAL TECHNOLOGY, INC. recalls Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is u
Recalled July 23, 2014 · FDA recall Z-2076-2014 · PIONEER SURGICAL TECHNOLOGY
Hazard
Lack of Sterility Assurance · FDA Class II
Units
5
Sold at
US Nationwide Distribution in the states of TX and FL
Description
Lack of Sterility Assurance
Product
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.
Manufacturer(s)
PIONEER SURGICAL TECHNOLOGY, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →