FDAClass IINovember 25, 2020

Clinic Pack 100 Pieces FG 57 100057C recall

Clinic Pack 100 Pieces FG 57 100057C (100057C)

Why was Clinic Pack 100 Pieces FG 57 100057C 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

J74027

Product
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Recalling firm
Coltene Whaledent Inc
Quantity
556
Distribution
Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Recall date
November 25, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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