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Open, Classified

FG 57 100057X (100057X)

FDA Recall Z-0465-2021 · Posted None

Recalling FirmColtene Whaledent Inc
Recall StatusOpen, Classified
Product CodeEJL
Date Initiated2020-10-20
Product Quantity556

Reason for Recall

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.

Firm Action

On October 20, 2020, the firm emailed Urgent Medical Device Recall letters to affected distributors. Customers were informed that the incorrect dental carbide bur was manufactured and subsequently packaged and distributed. Customers were asked to return the product to Coltene/Whaledent, Inc. by following the instructions in the letter. The firm will replace the product at no cost. Please inform the firm if you have already used the product. Distributors were asked to either identify and notify their customers who were shipped the affected product or to provide a list of affected customers to the recalling firm so that Coltene/Whaledent, Inc. could notify them.

Root Cause

Under Investigation by firm

Distribution Pattern

Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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