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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- PIONEER SURGICAL TECHNOLOGY, INC.
- Hazard
- Affected units
- 5
Distribution
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