Hiossen recalls Osstem Implant System ET Multi Abutments due to potential mislabeling of product versions, which could lead to incorrect dental implant use. Affected units include specific model numbers and 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
Hiossen is recalling Osstem Implant System ET Multi Abutments because the patient chart stickers inside the packaging may incorrectly label the product as a different version. This could lead to using the wrong implant abutment type, which might cause dental complications.
The patient chart stickers inside the packaging may incorrectly identify ET Rigid Abutments as Regular versions or ET Multi Abutments as Mini versions. This mislabeling could lead to using the wrong implant abutment type during dental procedures, potentially causing improper fit or function.
Dental professionals who purchased or use the Osstem Implant System ET Multi Abutments with model number ETMTA505RV1 and lot code H4E22B111 are affected. Patients using these abutments may face incorrect dental implant placement if the wrong version is used.
Check for model number ETMTA505RV1 and lot code H4E22B111 on the packaging or documentation. The product is intended for dental implants to support crowns, bridges, or overdentures.
Check the model number on the packaging or documentation to confirm it is ETMTA505RV1.
The specific model number is ETMTA505RV1.
The lot code is H4E22B111.
Yes, using the wrong abutment version could lead to improper fit or function during dental implant procedures.
We’ve drafted a message you can send Hiossen to request your refund or repair — edit it as you like.
Subject: Recall Z-1276-2025 — Hiossen Hiossen Hello, I own a Hiossen that is covered by recall Z-1276-2025 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.
