FDA Device recall Z-2076-2014
Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile
- FDA Device
- Class II
- terminated
- Published 2014-07-23
On 2014-07-23 the FDA classified a Class II recall of Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile by Pioneer Surgical Technology, citing lack of Sterility Assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2076-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-11 |
| Published | 2014-07-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Pioneer Surgical Technology |
| Distribution | US |
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
Lack of Sterility Assurance
Identifiers
| code_info | Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2076-2014%22
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