Class II — PIONEER SURGICAL TECHNOLOGY, INC.
| Recalling firm | Pioneer Surgical Technology, Inc. |
|---|---|
| Registered facility | Pioneer Surgical Technology, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Lack of Sterility Assurance |
| 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. |
| Quantity | 5 |
| Distribution | US Nationwide Distribution in the states of TX and FL |
| Initiated | 2014-06-11 |
| Classified | 2014-07-17 |
| Terminated | 2014-10-22 |
| Recall number | Z-2076-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PIONEER SURGICAL TECHNOLOGY, INC. (Z-2076-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68619/
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