Hiossen recalls Osstem Implant System abutments with incorrect chart stickers that may lead to using wrong dental implant sizes. Affected units include model ETMTA503RV1 sold with specific lot codes.
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
Hios: Hiossen recalls Osstem Implant System abutments that have stickers incorrectly labeling Mini versions as Regular and vice versa. This could lead to improper dental implant use if the wrong size is selected.
The packaging stickers incorrectly identify ET Rigid Abutments as Regular versions and ET Multi Abutments as Mini versions. This mismatch could lead to using the wrong implant size during dental procedures, potentially causing improper fit or function.
Dental professionals using Osstem Implant System abutments with model ETMTA503RV1 are most at risk. Patients receiving dental implants with these abutments may be affected if the wrong size is used.
Check for model number ETMTA503RV1 on the packaging. Look for lot codes UDI-DI: 00810019241529 or H4E21D092 on the product label.
Look for model number ETMTA503RV1 and lot codes UDI-DI: 00810019241529 or H4E21D092 on the packaging.
The model number is ETMTA503RV1.
Lot codes UDI-DI: 00810019241529 and H4E21D092 are associated with the recalled product.
The stickers incorrectly identify ET Rigid Abutments as Regular versions and ET Multi Abutments as Mini versions.
We’ve drafted a message you can send Hiossen to request your refund or repair — edit it as you like.
Subject: Recall Z-1274-2025 — Hiossen Hiossen Hello, I own a Hiossen that is covered by recall Z-1274-2025 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.