Drug recall
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
FDA recall event 89465 · Class II · Nobel Biocare Usa Llc
Key facts
| Event ID | 89465 |
|---|---|
| Recall numbers | Z-0658-2022 |
| Recalling firm | Nobel Biocare Usa Llc |
| Product type | Devices |
| Products | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a… |
| Initiation date | Dec 17, 2021 |
| Report date | Mar 2, 2022 |
| Termination date | Oct 25, 2024 |
| 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: