Drug recall
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and…
FDA recall event 76060 · Class II · Medtronic Navigation, Inc.
Key facts
| Event ID | 76060 |
|---|---|
| Recall numbers | Z-1007-2017 |
| Recalling firm | Medtronic Navigation, Inc. |
| Product type | Devices |
| Products | AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the… |
| Initiation date | Dec 12, 2016 |
| Report date | Jan 18, 2017 |
| Termination date | May 19, 2017 |
| City | Louisville |
| State | CO |
| Country | United States |
| FEI number | 1000517638 |
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: