Drug recall
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
FDA recall event 95998 · Class II · Stryker Corporation
Key facts
| Event ID | 95998 |
|---|---|
| Recall numbers | Z-0981-2025, Z-0982-2025 |
| Recalling firm | Stryker Corporation |
| Product type | Devices |
| Products | stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery, stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa). |
| Initiation date | Jun 28, 2023 |
| Report date | Jan 29, 2025 |
| City | Portage |
| State | MI |
| Country | United States |
| FEI number | 3015967359 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: