[Recalled] 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 supporting tooth replacements to resto
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | 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 supporting tooth replacements to restore chewing function. |
|---|---|
| Brand / manufacturer | NOBEL BIOCARE SERVICES AG |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2828-2020 |
| Country of notice | Switzerland |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 July 2020 |
| EAN / barcode | 13084072 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
This Class II recall concerns device products distributed in Switzerland and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.