Drug recall
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive…
FDA recall event 66918 · Class II · Intuitive Surgical, Inc.
Key facts
| Event ID | 66918 |
|---|---|
| Recall numbers | Z-0520-2014, Z-0521-2014 |
| Recalling firm | Intuitive Surgical, Inc. |
| Product type | Devices |
| Products | Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps…, Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. |
| Initiation date | Nov 15, 2013 |
| Report date | Dec 25, 2013 |
| Termination date | Sep 4, 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: