SIN SISTEMA DE IMPLANTE NACIONAL S.A 2025-01-22 Health serious FDA
Health · FDA · Recall #FDA-Z-0920-2025
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N Recall
Issued January 22, 2025 · SIN SISTEMA DE IMPLANTE NACIONAL S.A
In January 2025, SIN SISTEMA DE IMPLANTE NACIONAL S.A recalled the Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SIN SISTEMA DE IMPLANTE NACIONAL S.A to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SIN SISTEMA DE IMPLANTE NACIONAL S.A
- Category
- Health
- Recall date
- January 22, 2025
- Units affected
- Not reported
- Sold at
- US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
- Recall number
- FDA-Z-0920-2025
- Made in
- Brazil
- Issuing agency
- FDA
In context
- SIN SISTEMA DE IMPLANTE NACIONAL S.A has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.