HIGH

Over 4,300 S.I.N. Implant EPIKUT Dental Implants Recalled Due to Quality Concerns

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.

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

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

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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

  1. Check the model number on your dental implants against the listed recall model references.
  2. Consult your healthcare provider for any additional verification required.
  3. 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.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
4/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
ILM 3510N
ILM 3511N
ILM 3513N
ILM 3515N
ILM 3810N
+22 more
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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