Drug recall
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
FDA recall event 74799 · Class II · Straumann Manufacturing, Inc.
Key facts
| Event ID | 74799 |
|---|---|
| Recall numbers | Z-2534-2016, Z-2535-2016 |
| Recalling firm | Straumann Manufacturing, Inc. |
| Product type | Devices |
| Products | Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510, Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration |
| Initiation date | Jul 14, 2016 |
| Report date | Aug 24, 2016 |
| Termination date | Nov 20, 2020 |
| 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: