Tritium Sternal Plate System — Class II medical device recall Z-2076-2014
Terminated recall by PIONEER SURGICAL TECHNOLOGY, INC., reported 2014-07-23, distributed nationwide. Lack of Sterility Assurance
| Recall number | Z-2076-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PIONEER SURGICAL TECHNOLOGY, INC., Marquette, MI, United States |
| Recall initiated | 2014-06-11 |
| Classified | 2014-07-17 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2014-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00846468061463 |
| Lot numbers | 168952 |
| Model numbers | 86-27-12-S12 |
| Expiration dates | 2018-12-23 |
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.
Reason for recall
Lack of Sterility Assurance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2076-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.