Device recall
Z-0063-2025: 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming…
FDA device recall · Class II · Stryker Corporation
Key facts
| Recall number (Z-number) | Z-0063-2025 |
|---|---|
| Recall event | 95342 |
| Product | 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog… |
| Product code | HBE |
| Recalling firm | Stryker Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K143320 |
| FEI number | 3015967359 |
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