Device recall
Z-0980-2025: The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used…
FDA device recall · Class II · Stryker Corporation
Key facts
| Recall number (Z-number) | Z-0980-2025 |
|---|---|
| Recall event | 95996 |
| Product | The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications… |
| 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