Device recall
Z-1572-2022: SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers…
FDA device recall · Class II · SAFE ORTHOPAEDICS LLC
Key facts
| Recall number (Z-number) | Z-1572-2022 |
|---|---|
| Recall event | 90542 |
| Product | SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740. |
| Product code | NKB |
| Recalling firm | SAFE ORTHOPAEDICS LLC |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K201648 |
| FEI number | 3018359693 |
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