Devices

Device Recall Tritium Sternal Plate System

Model / Serial
Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution in the states of TX and FL
Product Description
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
PIONEER SURGICAL TECHNOLOGY, INC.
1 Event
- Recall of Device Recall Tritium Sternal Plate System

Manufacturer

PIONEER SURGICAL TECHNOLOGY, INC.

Manufacturer Address
PIONEER SURGICAL TECHNOLOGY, INC., 375 River Park Cir, Marquette MI 49855-1781
Manufacturer Parent Company (2017)
RTI Surgical Inc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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