Drug recall
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.5308…
FDA recall event 69379 · Class II · Straumann USA, LLC
Key facts
| Event ID | 69379 |
|---|---|
| Recall numbers | Z-0117-2015 |
| Recalling firm | Straumann USA, LLC |
| Product type | Devices |
| Products | Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) |
| Initiation date | Sep 19, 2014 |
| Report date | Oct 29, 2014 |
| Termination date | Mar 13, 2015 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 1000121052 |
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: