Tritium Sternal Plate System recall: Sterility Concern
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.
Why was Tritium Sternal Plate System recalled?
Lack of Sterility Assurance
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018
- 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.
- Recalling firm
- PIONEER SURGICAL TECHNOLOGY, INC.
- Quantity
- 5
- Distribution
- US Nationwide Distribution in the states of TX and FL
- Recall date
- July 23, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)