Coltene Whaledent recalls FG 57 100057X burs that may remove more material than intended, causing potential damage to dental work. Affected users should contact the company for details.
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.
Coltene Whaledent is recalling FG 57 100057X dental burs because they were incorrectly packaged as FG 57 burs. These burs may remove more material than intended, potentially damaging dental work.
The FG 557 burs (mistakenly labeled as FG 57) remove more material than intended. This could lead to damage to dental work if used incorrectly. The hazard is due to packaging errors, not active failure.
Dental professionals using the FG 57 100057X burs are likely affected. The risk is low as the issue involves incorrect packaging rather than immediate danger.
Check for the model number 100057X on the burs. The product was sold under the J79552 code.
Look for the model number 100057X on the burs to confirm if they are affected.
The FG 557 burs were incorrectly packaged as FG 57 burs and may remove more material than intended.
Check for the model number 100057X on the burs. The product was sold under the J79552 code.
The recall record does not specify a remedy, so contact Coltene Whaledent directly for further instructions.
We’ve drafted a message you can send Coltene Whaledent to request your refund or repair — edit it as you like.
Subject: Recall Z-0465-2021 — Coltene Whaledent Coltene Whaledent Hello, I own a Coltene Whaledent that is covered by recall Z-0465-2021 from Coltene Whaledent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
