Coltene Whaled: Strauss 25 Carbide Dental Burs (100057XXV) recalled due to incorrect packaging causing excessive material removal 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 Strauss 25 Carbide Dental Burs (100057XXV) because they were incorrectly packaged as FG 57 burs instead of FG 557 burs. This means the burs remove more material than intended, which could lead to complications during dental work.
The FG 557 burs were incorrectly labeled as FG 57 burs. This causes them to remove more dental material than intended, potentially leading to complications during procedures. However, the hazard is not severe enough to cause immediate injury.
Dental professionals who own or use Strauss 25 Carbide Dental Burs (100057XXV) are affected. The risk is low as the issue relates to incorrect packaging rather than immediate safety hazards.
Check for the model number 100057XXV on the Strauss 25 Carbide Dental Burs. The product was sold under the part numbers J77147 and J93636.
Verify the model number on the burs to confirm they are 100057XXV.
The FG 557 burs were incorrectly packaged as FG 57 burs, causing them to remove more material than intended.
The recall does not specify a remedy, so check the model number and contact the manufacturer if needed.
The hazard is low risk as the issue is related to incorrect packaging and not immediate safety hazards.
We’ve drafted a message you can send Coltene Whaledent to request your refund or repair — edit it as you like.
Subject: Recall Z-0468-2021 — Coltene Whaledent Coltene Whaledent Hello, I own a Coltene Whaledent that is covered by recall Z-0468-2021 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.
