Drug recall
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel…
FDA recall event 65442 · Class II · SpineFrontier, Inc.
Key facts
| Event ID | 65442 |
|---|---|
| Recall numbers | Z-1666-2013 |
| Recalling firm | SpineFrontier, Inc. |
| Product type | Devices |
| Products | InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for set screw to be come deformed. |
| Initiation date | May 7, 2013 |
| Report date | Jul 10, 2013 |
| Termination date | Jan 11, 2016 |
| City | Beverly |
| State | MA |
| Country | United States |
| FEI number | 3005977257 |
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: