Coltene Whaledent recalls Alpen Clinic 100 Carbide Instruments (R100057C) due to incorrect packaging of FG 557 burs that remove more material than FG 57 burs.
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 Alpen Clinic 100 Carbide Instruments (R100057C) because the FG 557 burs were incorrectly packaged as FG 57 burs. This could cause the burs to remove more material than intended, potentially leading to improper dental work.
The FG 557 burs were incorrectly labeled as FG 57 burs. FG 557 burs remove more material than FG 57 burs, which could lead to improper dental work if used in place of the correct bur.
Dentists and dental clinics using Alpen Clinic 100 Carbide Instruments (R100057C) with the FG 557 burs. Those most at risk are dental professionals who may use the burs for dental procedures.
Check for Alpen Clinic 100 Carbide Instruments (R100057C) with the model number J75023. The burs may be labeled as FG 557 but incorrectly packaged as FG 57.
Look for the model number J75023 on the Alpen Clinic 100 Carbide Instruments packaging.
The FG 557 burs were incorrectly packaged as FG 57 burs, which could cause them to remove more material than intended.
Check the product label for model number J75023. If you have the FG 557 burs, you may need to contact the manufacturer for guidance.
The recall is for potential improper dental work, not a risk of serious injury. The hazard level is low risk.
We’ve drafted a message you can send Coltene Whaledent to request your refund or repair — edit it as you like.
Subject: Recall Z-0464-2021 — Coltene Whaledent Coltene Whaledent Hello, I own a Coltene Whaledent that is covered by recall Z-0464-2021 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.
