Drug recall
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer…
FDA recall event 74839 · Class II · Hologic, Inc
Key facts
| Event ID | 74839 |
|---|---|
| Recall numbers | Z-2765-2016, Z-2766-2016 |
| Recalling firm | Hologic, Inc |
| Product type | Devices |
| Products | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator…, SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Tip Breakage at the glue joint between the obturator body and tip |
| Initiation date | Aug 2, 2016 |
| Report date | Sep 14, 2016 |
| Termination date | Mar 30, 2017 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 1000120743 |
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: