Device recall
Z-1350-2021: NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail…
FDA device recall · Class II · Nuvasive Specialized Orthopedics Inc
Key facts
| Recall number (Z-number) | Z-1350-2021 |
|---|---|
| Recall event | 87353 |
| Product | NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod… |
| Product code | HSB |
| Recalling firm | Nuvasive Specialized Orthopedics Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K113695 |
| FEI number | 3006179046 |
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