Drug recall
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a…
FDA recall event 64452 · Class II · Ebi, Llc
Key facts
| Event ID | 64452 |
|---|---|
| Recall numbers | Z-0954-2013 |
| Recalling firm | Ebi, Llc |
| Product type | Devices |
| Products | Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Increased risk of failure at the driver tip during screw insertion or removal. |
| Initiation date | Feb 7, 2013 |
| Report date | Mar 27, 2013 |
| Termination date | Dec 7, 2015 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 2242816 |
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: