Drug recall
The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product…
FDA recall event 70088 · Class II · Integra LifeSciences Corporation
Key facts
| Event ID | 70088 |
|---|---|
| Recall numbers | Z-1084-2015 |
| Recalling firm | Integra LifeSciences Corporation |
| Product type | Devices |
| Products | The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use. |
| Initiation date | Dec 19, 2014 |
| Report date | Feb 18, 2015 |
| Termination date | Feb 22, 2017 |
| City | Cincinnati |
| State | OH |
| Country | United States |
| FEI number | 3004608878 |
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: