Device recall
Z-1118-2025: UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002…
FDA device recall · Class II · Medicrea International
Key facts
| Recall number (Z-number) | Z-1118-2025 |
|---|---|
| Recall event | 95957 |
| Product | UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to… |
| Product code | LLZ |
| Recalling firm | Medicrea International |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K212005 |
| FEI number | 1000432246 |
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