Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Implant Epikut S Plus CM 16-Degrees 4 Recalled by SIN SISTEMA DE IMPLANTE NACIONAL S.A Due to Dental implant box incorrectly labels the diameter as...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SIN SISTEMA DE IMPLANTE NACIONAL S.A directly.
Affected Products
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Quantity: 123 (US 98, OUS 25)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 10 states: CA, CO, FL, ID, IL, KY, NJ, NY, OH, TX
About SIN SISTEMA DE IMPLANTE NACIONAL S.A
SIN SISTEMA DE IMPLANTE NACIONAL S.A has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report