Pioneer Surgical Technology Recalls Tritium Sternal Plate System Due to Sterility Concerns
Pioneer Surgical Technology is recalling 5 units of the Tritium Sternal Plate System in Texas and Florida due to a lack of sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in a medical device, which poses a risk of harm where injury has not yet been reported.
Plain-English summary
Pioneer Surgical Technology, Inc. is recalling 5 units of the Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The recall is being conducted because of a lack of sterility assurance. The product is used for the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
The affected product is identified by Model 86-27-12-S12, UDI Number 00846468061463, and Lot 168952, with an expiration date of 12/23/2018. The recall covers units distributed nationwide in the states of Texas and Florida.
Healthcare facilities and consumers should stop using the affected product and contact Pioneer Surgical Technology for further instructions.
The recalled product
- 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 surgica
- Manufacturer
- PIONEER SURGICAL TECHNOLOGY, INC.
- Hazard
- Affected units
- 5
Distribution
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