Quick Facts at a Glance
- Recall Date
- July 30, 2025
- Hazard Level
- HIGH
- Brand
- S.I.N. Implant System Ltda
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- S.I.N. Implant System Ltda
- Product type
- Dental Implants
- Model numbers
- ILM 3510N, ILM 3511N, ILM 3513N, ILM 3515N, ILM 3810N, ILM 3811N, ILM 3815N, ILM 4010N +19 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 30, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Check the model number on your dental implants against the listed recall model references.
- Consult your healthcare provider for any additional verification required.
- Keep a record of your implant's details and purchase for easy reference during the recall process.
Where to find product info
Model numbers can typically be found on the packaging or device labels. Check any accompanying documents provided with the implants.
What timeline to expect
4-6 weeks for processing returns or refunds.
If the manufacturer is unresponsive
- Contact the manufacturer again for follow-up.
- Document any communication attempts.
- Consider filing a complaint with relevant health agencies if concerns persist.
How to prevent similar issues
- When purchasing dental implants, always review storage and handling conditions provided by the manufacturer.
- Ensure implants have valid certifications and compliance with health regulations.
- Ask healthcare providers about the supplier and verify the quality assurance measures in place.
Documentation advice
Keep all purchase receipts, correspondence with the manufacturer, and any other relevant documentation regarding the recall for your records.
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 4,367 dental implants recalled
- Imported under improper storage conditions
- Packaging damage may compromise quality
- Recall initiated on July 30, 2025
- Distributed nationwide in multiple states
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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