Drug recall
APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree…
FDA recall event 64578 · Class II · Spinal Solutions, LLC
Key facts
| Event ID | 64578 |
|---|---|
| Recall numbers | Z-1157-2013 |
| Recalling firm | Spinal Solutions, LLC |
| Product type | Devices |
| Products | APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might… |
| Initiation date | Mar 8, 2013 |
| Report date | May 1, 2013 |
| Termination date | Mar 26, 2014 |
| City | Murrieta |
| State | CA |
| Country | United States |
| FEI number | 3004884943 |
At a glance
- 1–9 Products in this recall
- None 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: