FDA Device recall Z-0464-2021
Alpen Clinic 100 Carbide Instruments (R100057C)
- FDA Device
- Class II
- ongoing
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of Alpen Clinic 100 Carbide Instruments (R100057C) by Coltene Whaledent, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0464-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-10-20 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Coltene Whaledent |
| Distribution | FL, NV, PA, TN, TX |
Product
Alpen Clinic 100 Carbide Instruments (R100057C)
Reason
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.
Identifiers
| code_info | J75023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0464-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.