Drug recall
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI…
FDA recall event 85236 · Class II · Nobel Biocare Usa Llc
Key facts
| Event ID | 85236 |
|---|---|
| Recall numbers | Z-1851-2020 |
| Recalling firm | Nobel Biocare Usa Llc |
| Product type | Devices |
| Products | NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the… |
| Initiation date | Aug 28, 2019 |
| Report date | May 13, 2020 |
| Termination date | Apr 28, 2021 |
| City | Yorba Linda |
| State | CA |
| Country | United States |
| FEI number | 1000125598 |
At a glance
- 1–9 Products in this recall
- 10–99 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: