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

Class I - Dangerous

What Should You Do?

Check if you have this product:
UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Company:: SIN SISTEMA DE IMPLANTE NACIONAL S.A
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

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

UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01

Distributed in: US, KY, CO, CA, NY, ID, NJ, FL, TX, IL, OH

Always verify recall information with the official FDA source:

FDA Recall Number: Z-0920-2025