Drug recall
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
FDA recall event 86048 · Class II · Mako Surgical Corporation
Key facts
| Event ID | 86048 |
|---|---|
| Recall numbers | Z-2745-2020 |
| Recalling firm | Mako Surgical Corporation |
| Product type | Devices |
| Products | Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures. |
| Initiation date | Jul 9, 2020 |
| Report date | Aug 12, 2020 |
| Termination date | Jun 16, 2023 |
| 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: