Drug recall
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided…
FDA recall event 70291 · Class II · Brainlab AG
Key facts
| Event ID | 70291 |
|---|---|
| Recall numbers | Z-1215-2015 |
| Recalling firm | Brainlab AG |
| Product type | Devices |
| Products | The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level. |
| Initiation date | Jan 16, 2015 |
| Report date | Mar 4, 2015 |
| 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: