Drug recall
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later…
FDA recall event 86700 · Class II · Mako Surgical Corporation
Key facts
| Event ID | 86700 |
|---|---|
| Recall numbers | Z-0472-2021 |
| Recalling firm | Mako Surgical Corporation |
| Product type | Devices |
| Products | Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the… |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to… |
| Initiation date | Oct 23, 2020 |
| Report date | Nov 25, 2020 |
| City | Davie |
| State | FL |
| Country | United States |
| FEI number | 3005985723 |
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: