Coltene Whaledent Inc recalls Alpen Clinic 100 Carbide Instruments (R100057C)
- Recall date
- October 20, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0464-2021
- FDA classification
- Class II
- Brand / firm
- Coltene Whaledent Inc
- Sold / distributed
- Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Alpen Clinic 100 Carbide Instruments (R100057C)
Get recall alerts
Free email alert whenever Coltene Whaledent Inc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Coltene Whaledent Inc