Drug recall
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45…
FDA recall event 78908 · Class II · Intuitive Surgical, Inc.
Key facts
| Event ID | 78908 |
|---|---|
| Recall numbers | Z-0404-2018 |
| Recalling firm | Intuitive Surgical, Inc. |
| Product type | Devices |
| Products | daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit… |
| Initiation date | Sep 19, 2017 |
| Report date | Jan 31, 2018 |
| Termination date | Jan 30, 2024 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 3001675293 |
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: