Coltene Whaledent recalls Clinic Pack 100 Pieces FG 57 100057C (100057C) because the FG 557 burs may remove more material than intended, potentially causing damage during dental procedures.
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 Clinic Pack 100 Pieces FG 57 100057C (100057C) because the burs in this pack are incorrectly labeled as FG 57 but are actually FG 557. This could cause excessive material removal during dental procedures, leading to potential damage to teeth or equipment.
The FG 557 burs in this pack remove more material than the FG 57 burs are designed to handle. This could lead to excessive tooth or dental structure removal during procedures, potentially causing damage to teeth or equipment.
Dental professionals using the Clinic Pack 100 Pieces FG 57 100057C (100057C) are likely affected. Patients and dental staff are at risk if the incorrect burs cause damage during procedures.
Check for the product name 'Clinic Pack 100 Pieces FG 57 100057C (100057C)' on the packaging. This product was sold under the J74027 code.
Look for the product name 'Clinic Pack 100 Pieces FG 57 100057C (100057C)' on the packaging.
The FG 557 burs in this pack are incorrectly labeled as FG 57 burs and may remove more material than intended, potentially causing damage during dental procedures.
Check for the product name 'Clinic Pack 100 Pieces FG 57 100057C (100057C)' on the packaging. This product was sold under the J74027 code.
The recall record does not specify a remedy, so contact the manufacturer directly for guidance.
We’ve drafted a message you can send Coltene Whaledent to request your refund or repair — edit it as you like.
Subject: Recall Z-0466-2021 — Coltene Whaledent Coltene Whaledent Hello, I own a Coltene Whaledent that is covered by recall Z-0466-2021 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.
