FG 57 100057X recall
FG 57 100057X (100057X)
Why was FG 57 100057X 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?
J79552
- Product
- FG 57 100057X (100057X)
- 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)