Coltene Whaledent recalls CEI Cutting Edge PTC-57C dental instruments due to incorrect packaging causing excessive material removal. Affected units may cause damage to dental work.
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 CEI Cutting Edge Instruments (PTC-57C) because the FG 557 burs were incorrectly labeled as FG 57 burs. This can cause more material to be removed than intended, potentially damaging dental work.
The FG 557 burs remove more material than the FG 57 burs due to incorrect packaging. This mismatch means the instruments may cause excessive tooth reduction during procedures, potentially damaging dental work.
Dental professionals using CEI Cutting Edge PTC-57C instruments with the FG 557 model are most at risk. Patients receiving dental work with these instruments could experience unintended damage.
Check for CEI Cutting Edge Instruments (PTC-57C) with model number J88954. The FG 557 burs were incorrectly labeled as FG 57 burs in the packaging.
Verify the model number on the instrument packaging or label to confirm it is not J88954.
The FG 557 burs were incorrectly packaged as FG 57 burs, causing them to remove more material than intended.
Excessive material removal during dental procedures could damage dental work.
Check for CEI Cutting Edge Instruments (PTC-57C) with model number J88954.
We’ve drafted a message you can send Coltene Whaledent to request your refund or repair — edit it as you like.
Subject: Recall Z-0467-2021 — Coltene Whaledent Coltene Whaledent Hello, I own a Coltene Whaledent that is covered by recall Z-0467-2021 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.
