Drug recall
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for…
FDA recall event 67017 · Class II · Brainlab AG
Key facts
| Event ID | 67017 |
|---|---|
| Recall numbers | Z-0967-2014 |
| Recalling firm | Brainlab AG |
| Product type | Devices |
| Products | BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the… |
| Initiation date | Nov 15, 2013 |
| Report date | Feb 19, 2014 |
| Termination date | Mar 13, 2017 |
| City | Feldkirchen |
| Country | Germany |
| FEI number | 3002619595 |
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: