Hiossen recalls dental implant system ET NH Model ET3R5010B due to mislabeled size on packaging. The implant is labeled as 5.0mm x 10mm but should be 5.0mm x 8.5mm. Affected units sold with specific lot numbers.
Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm
Hiossen is recalling a dental implant system because the packaging incorrectly labels the implant size as 5.0mm x 10mm instead of the correct 5.0mm x 8.5mm. This mismatch could lead to improper implant placement if used without verifying the actual size.
The dental implant is labeled as 5.0mm x 10mm but should be 5.0mm x 8.5mm. Using the wrong size could cause improper fit or damage to the jawbone during implant placement, potentially requiring additional surgery.
Dental professionals who purchased the ET III Nano-HA fixture system with model number ET3R5010B and lot number H1E22J263 are affected. Patients using this implant system may be at risk if the incorrect size is used during procedures.
Check for the model number ET3R5010B and lot number H1E22J263 on the packaging. The implant is part of the ET III Nano-HA fixture system for dental implants.
Check the actual implant size against the packaging label. The correct size is 5.0mm x 8.5mm, but it is labeled as 5.0mm x 10mm.
The implant is mislabeled on the packaging as 5.0mm x 10mm instead of the correct 5.0mm x 8.5mm size.
Look for the model number ET3R5010B and lot number H1E22J263 on the packaging of the ET III Nano-HA fixture system.
The recall does not specify a return process, but you should verify the implant size to ensure proper use.
We’ve drafted a message you can send Hiossen to request your refund or repair — edit it as you like.
Subject: Recall Z-1604-2023 — Hiossen Hiossen Hello, I own a Hiossen that is covered by recall Z-1604-2023 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.
