S.I.N. Implant System Ltda recalled 4,367 dental implants after reports of potential packaging damage. Improper temperature and storage conditions may compromise product quality and performance. Patients and healthcare providers should stop using these implants immediately and follow the manufacturer's instructions for return.
Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact S.I.N. Implant System Ltda or your healthcare provider for instructions. Notification method: Letter
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The EPIKUT Plus dental implants are designed for dental procedures requiring high reliability and durability. These implants are commonly used in restorative dental work for patients needing replacements for lost or damaged teeth.
Improper handling during importation may lead to physical damage to packaging. Such damage can cause degradation in the quality and performance of the dental implants, rendering them potentially unsafe for use.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face immediate safety concerns due to potential quality issues with the dental implants. The need to stop using the products may lead to increased costs and delays in dental treatments.
Model numbers can typically be found on the packaging or device labels. Check any accompanying documents provided with the implants.
4-6 weeks for processing returns or refunds.
Keep all purchase receipts, correspondence with the manufacturer, and any other relevant documentation regarding the recall for your records.
Model References: ILM 3510N, ILM 3511N, ILM 3513N, ILM 3515N and others. Sold: Nationwide in the US, including states like TX, IL, CA, NY, and FL. Recall Date: July 30, 2025.
No injuries or incidents have been reported.
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