Device recall
Z-0322-2021: Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN…
FDA device recall · Class II · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Key facts
| Recall number (Z-number) | Z-0322-2021 |
|---|---|
| Recall event | 86595 |
| Product | Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device. |
| Product code | OLO |
| Recalling firm | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K200095 |
| 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