Drug recall
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation…
FDA recall event 73978 · Class II · Orthofix, Inc
Key facts
| Event ID | 73978 |
|---|---|
| Recall numbers | Z-1881-2016 |
| Recalling firm | Orthofix, Inc |
| Product type | Devices |
| Products | Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle. |
| Initiation date | Apr 27, 2016 |
| Report date | Jun 8, 2016 |
| Termination date | Nov 23, 2016 |
| 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: