Device recall
Z-1649-2022: Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation…
FDA device recall · Class II · New Standard Device Inc
Key facts
| Recall number (Z-number) | Z-1649-2022 |
|---|---|
| Recall event | 90670 |
| Product | Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF… |
| Product code | KTT |
| Recalling firm | New Standard Device Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K181630 |
| FEI number | 3013365802 |
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