Device recall
Z-1884-2017: 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is…
FDA device recall · Class II · XTANT MEDICAL INC
Key facts
| Recall number (Z-number) | Z-1884-2017 |
|---|---|
| Recall event | 76842 |
| Product | 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle… |
| Product code | MNH |
| Recalling firm | XTANT MEDICAL INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2017 |
| 510(k) numbers | K120832 |
| FEI number | 3005031160 |
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