Drug recall
Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT…
FDA recall event 72878 · Class II · Innovasis, Inc
Key facts
| Event ID | 72878 |
|---|---|
| Recall numbers | Z-0662-2016 |
| Recalling firm | Innovasis, Inc |
| Product type | Devices |
| Products | Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. |
| Initiation date | Dec 7, 2015 |
| Report date | Jan 27, 2016 |
| Termination date | Apr 7, 2016 |
| City | Salt Lake City |
| State | UT |
| Country | United States |
| FEI number | 3004719693 |
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: