Hiossen recalls ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H due to incorrect chart stickers that may mislabel Mini versions as Regular and vice versa. This could lead to improper dental implant use.
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version
Hiossen is recalling a specific dental implant support device because packaging stickers might incorrectly label Mini versions as Regular and vice versa. Using the wrong version could cause improper dental implant support.
The patient chart stickers inside the packaging may misidentify Mini versions as Regular and Regular versions as Mini. This could lead to using the wrong size for dental implants, potentially causing improper support or complications.
Dental professionals who purchased the ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H model. Patients using this device for dental implants are at risk if the wrong version is used.
Check for the model number ETRGA4515MP on the packaging. The product was sold with lot number H4E20K117 and may have been distributed in the U.S. with the UDI-DI 00814913026350.
Look for the model number ETRGA4515MP on the packaging to confirm the correct version.
The recall is due to labeling errors, not a safety issue with the product itself. Using the correct version as intended should be safe.
Check for the model number ETRGA4515MP and lot number H4E20K117 on the packaging.
The recall does not require immediate action; check the product label to confirm the version before use.
We’ve drafted a message you can send Hiossen to request your refund or repair — edit it as you like.
Subject: Recall Z-1271-2025 — Hiossen Hiossen Hello, I own a Hiossen that is covered by recall Z-1271-2025 from Hiossen. 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.
