[Recalled] Alpen Clinic 100 Carbide Instruments (R100057C) — The FG 557 bur was incorrectly packaged as the FG 57 bur | FDA 2020-10-20
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Alpen Clinic 100 Carbide Instruments (R100057C) |
|---|---|
| Brand / manufacturer | Coltene Whaledent Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0464-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 October 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
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 →
Related recalls from Coltene Whaledent Inc
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.