Device recall
Z-0500-2025: Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight…
FDA device recall · Class II · NuVasive Specialized Orthopedics, Inc.
Key facts
| Recall number (Z-number) | Z-0500-2025 |
|---|---|
| Recall event | 95567 |
| Product | Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis… |
| Product code | HSB |
| Recalling firm | NuVasive Specialized Orthopedics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K232267 |
| 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