Device recall
Z-0534-2020: Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number…
FDA device recall · Class II · Nextremity Solutions
Key facts
| Recall number (Z-number) | Z-0534-2020 |
|---|---|
| Recall event | 84160 |
| Product | Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments… |
| Product code | HRS |
| Recalling firm | Nextremity Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 24, 2020 |
| 510(k) numbers | K182201 |
| FEI number | 3009540749 |
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