Hiossen Inc. is recalling 240 dental abutments, including various ET Rigid and Osstem ET Multi models, because the patient chart stickers included in the packaging are mislabeled. These stickers incorrectly identify the size or version of the abutment, which is a component used to support dental crowns and bridges. No injuries or incidents have been reported, but the mislabeling could lead to inaccurate patient medical records.
If an incorrect patient chart sticker is used, the patient's permanent dental record will contain inaccurate information about the size and type of their implant components. This could result in clinicians using the wrong parts during future maintenance or replacement procedures, potentially leading to treatment delays or errors.
Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.