S.I.N. Implant System Ltda recalled 4,367 dental implants on July 30, 2025, due to improper storage conditions. The recalled products may have compromised packaging, affecting their quality and performance. Patients and healthcare providers should stop using these devices immediately.
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 recall includes multiple models of EPIKUT PLUS MT16 dental implants, identified by reference numbers ILM 3510N through ILM 3820N. The products were distributed nationwide in the U.S., including states such as TX, CA, and FL. The quantity recalled is 4,367.
Improper temperature and storage conditions during importation may have led to packaging damage. This damage could compromise the quality and performance of the dental implants, posing a risk to patients.
There have been no specific injury reports associated with this recall. However, the potential for compromised product performance raises serious concerns regarding patient safety.
Patients and healthcare providers should stop using the recalled dental implants immediately. Contact S.I.N. Implant System Ltda or your healthcare provider for further instructions and follow the manufacturer's recall guidelines.
For more information, contact S.I.N. Implant System Ltda at their customer service number or visit their website. Additional details can be found on the FDA recall page.
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