Drug recall
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI…
FDA recall event 68553 · Class II · Intuitive Surgical, Inc.
Key facts
| Event ID | 68553 |
|---|---|
| Recall numbers | Z-2020-2014 |
| Recalling firm | Intuitive Surgical, Inc. |
| Product type | Devices |
| Products | Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories.. |
| Initiation date | Jun 13, 2014 |
| Report date | Jul 16, 2014 |
| Termination date | Dec 1, 2014 |
| 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: