Device recall
Z-1127-2020: Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The…
FDA device recall · Class II · Nextremity Solutions
Key facts
| Recall number (Z-number) | Z-1127-2020 |
|---|---|
| Recall event | 84694 |
| Product | Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation. |
| Product code | HRS |
| Recalling firm | Nextremity Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 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