Drug recall
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular…
FDA recall event 66969 · Class II · Orthofix, Inc.
Key facts
| Event ID | 66969 |
|---|---|
| Recall numbers | Z-0855-2014 |
| Recalling firm | Orthofix, Inc. |
| Product type | Devices |
| Products | Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the… |
| Initiation date | Nov 26, 2013 |
| Report date | Feb 5, 2014 |
| Termination date | Dec 9, 2014 |
| City | Lewisville |
| State | TX |
| Country | United States |
| FEI number | 2183449 |
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: