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Coltene Whaledent Inc recalls Alpen Clinic 100 Carbide Instruments (R100057C)
Recalled November 25, 2020 · FDA recall Z-0464-2021 · Coltene Whaledent
Hazard
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. · FDA Class II
Units
556 packs
Sold at
Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Description
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.
Product
Alpen Clinic 100 Carbide Instruments (R100057C)
Manufacturer(s)
Coltene Whaledent Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →