Drug recall
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be…
FDA recall event 86085 · Class II · NOBEL BIOCARE SERVICES AG
Key facts
| Event ID | 86085 |
|---|---|
| Recall numbers | Z-2828-2020 |
| Recalling firm | NOBEL BIOCARE SERVICES AG |
| Product type | Devices |
| Products | NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second… |
| Initiation date | Jul 20, 2020 |
| Report date | Aug 26, 2020 |
| Termination date | May 12, 2021 |
| City | Kloten |
| Country | Switzerland |
| FEI number | 3008693672 |
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: