Drug recall
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA recall event 95277 · Class II · Howmedica Osteonics Corp.
Key facts
| Event ID | 95277 |
|---|---|
| Recall numbers | Z-0044-2025 |
| Recalling firm | Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces. |
| Initiation date | Aug 7, 2024 |
| Report date | Oct 16, 2024 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3003070421 |
At a glance
- 1–9 Products in this recall
- 10–99 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: