Drug recall
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm…
FDA recall event 63549 · Class II · TITAN SPINE, LLC
Key facts
| Event ID | 63549 |
|---|---|
| Recall numbers | Z-0535-2013 |
| Recalling firm | TITAN SPINE, LLC |
| Product type | Devices |
| Products | Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use. |
| Initiation date | Oct 19, 2012 |
| Report date | Dec 26, 2012 |
| Termination date | Jan 14, 2013 |
| City | Mequon |
| State | WI |
| Country | United States |
| FEI number | 3006340236 |
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: