Device recall
Z-2616-2014: Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The…
FDA device recall · Class II · PIONEER SURGICAL TECHNOLOGY, INC.
Key facts
| Recall number (Z-number) | Z-2616-2014 |
|---|---|
| Recall event | 69036 |
| Product | Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion… |
| Product code | NKB |
| Recalling firm | PIONEER SURGICAL TECHNOLOGY, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2014 |
| 510(k) numbers | K130286 |
| FEI number | 1000115331 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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