[Recalled] NEODENT CM Intraoral Scanbody, Article Number: 108.139 — During internal testing, Neodent determined that the body diameter (3.8mm) of t… | FDA 2017-03-13
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | NEODENT CM Intraoral Scanbody, Article Number: 108.139 |
|---|---|
| Brand / manufacturer | Instradent USA, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1831-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 13 March 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.
This Class II recall concerns device products distributed in United States 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 →
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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.