Drug recall
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
FDA recall event 82738 · Class II · Mako Surgical Corporation
Key facts
| Event ID | 82738 |
|---|---|
| Recall numbers | Z-1823-2019, Z-1824-2019 |
| Recalling firm | Mako Surgical Corporation |
| Product type | Devices |
| Products | 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only), 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The bearings of the saw attachments were ungreased. |
| Initiation date | Apr 25, 2019 |
| Report date | Jun 26, 2019 |
| Termination date | Apr 22, 2021 |
| 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: