Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tritium Sternal Plate System Recalled by PIONEER SURGICAL TECHNOLOGY, INC. Due to Lack of Sterility Assurance
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PIONEER SURGICAL TECHNOLOGY, INC. directly.
Affected 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.
Quantity: 5
Why Was This Recalled?
Lack of Sterility Assurance
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PIONEER SURGICAL TECHNOLOGY, INC.
PIONEER SURGICAL TECHNOLOGY, INC. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report