Device recall
Z-2076-2014: Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The…
FDA device recall · Class II · PIONEER SURGICAL TECHNOLOGY, INC.
Key facts
| Recall number (Z-number) | Z-2076-2014 |
|---|---|
| Recall event | 68619 |
| 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… |
| Product code | JDQ |
| Recalling firm | PIONEER SURGICAL TECHNOLOGY, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 22, 2014 |
| 510(k) numbers | K133785 |
| FEI number | 1000115331 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database