Drug recall
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and…
FDA recall event 68362 · Class II · SeaSpine Inc
Key facts
| Event ID | 68362 |
|---|---|
| Recall numbers | Z-1841-2014 |
| Recalling firm | SeaSpine Inc |
| Product type | Devices |
| Products | Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become… |
| Initiation date | May 21, 2014 |
| Report date | Jul 2, 2014 |
| Termination date | Dec 15, 2014 |
| City | Vista |
| State | CA |
| Country | United States |
| FEI number | 3003790069 |
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: