Device 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.
Z-2076-2014
Product summary
- Event
- Event 68619
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-2076-2014
Official wording
Reason: Lack of Sterility Assurance
Code information: Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018
Distribution pattern: US Nationwide Distribution in the states of TX and FL
Derived failure modes
-
Sterility assurance
Lack of Sterility