High RiskFDAfda-Z-0920-2025OTHER

Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

Q: What is being recalled?

Sin Sistema De Implante Nacional S.a is the subject of a medical implants safety report: Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N. The notice was published on September 1, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 123 units are potentially affected.

Q: Why was this product recalled?

This recall was issued in connection with a other concern. The full description above contains the FDA's official wording about the defect, affected lots, and impacted distribution — read it carefully.

Q: What should I do if I have this product?

Stop using the product. Check the lot number, model number, or sell-by date against the recall notice above. Then contact Sin Sistema De Implante Nacional S.a or the retailer where you purchased it to request a refund, replacement, or repair. The official FDA page has the most current instructions: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.

Q: Is a refund or replacement free?

Yes. Under federal recall procedures, consumers are entitled to a remedy at no cost — typically a full refund, free replacement, or free repair. There is generally no expiration on safety recalls. Keep your receipt if possible, but most agencies require remedies even without proof of purchase.

Q: Has anyone been hurt by this product?

Injury and incident reports are part of the official recall announcement above. If you or a member of your household has been harmed by this product, report the incident to FDA at https://www.fda.gov/safety/report-problem-fda. Reports help the agency identify ongoing risks and pursue follow-up enforcement.

Q: Where can I get more information?

The U.S. Food and Drug Administration (FDA) is the authoritative source for this recall. Visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts for the complete recall notice, lot codes, and the manufacturer's contact information.

Q: Is this an FDA food or cosmetic recall?

This recall is in the FDA's jurisdiction and may cover food, dietary supplements, cosmetics, or related products. Follow the FDA's official guidance in the notice above. If you have consumed the product and are concerned about your health, contact a healthcare provider.

Brand

Sin Sistema De Implante Nacional S.a

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0920-2025.

Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0920-2025.

Recall ongoing. Follow firm instructions.

✅ What you should do

Stop using the product if you own it.
Check the model number, lot code, or sell-by date against the recall notice above.
Contact Sin Sistema De Implante Nacional S.a or the retailer where you bought it for a refund, replacement, or repair.
For the most current official instructions, visit the FDA recall page.
If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0920-2025.

SIN SISTEMA DE IMPLANTE NACIONAL S.A

Official Source

FDA Recalls

U.S. Food and Drug Administration

Report an Incident

File a Complaint

Reports inform future enforcement

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

Visit FDA.gov →

📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

How to report to FDA →File a report at FDA →

Sin Sistema De Implante Nacional S.a Recall FAQ

What is being recalled?

Sin Sistema De Implante Nacional S.a is the subject of a medical implants safety report: Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N. The notice was published on September 1, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 123 units are potentially affected.

Why was this product recalled?

What should I do if I have this product?

Is a refund or replacement free?

Has anyone been hurt by this product?

Where can I get more information?

Is this an FDA food or cosmetic recall?

Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

FDA Recall Notice

Corrective Action (per FDA)

✅ What you should do

Consumer Contact (per FDA)

About the U.S. Food and Drug Administration

📣 Report a food, supplement, or cosmetic problem to the FDA

Sin Sistema De Implante Nacional S.a Recall FAQ

Other medical implants recalls