SIN SISTEMA DE IMPLANTE NACIONAL S.A: Device Recall
Recall #Z-0920-2025 · 09/01/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0920-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- SIN SISTEMA DE IMPLANTE NACIONAL S.A
- Status
- Ongoing
- Date Initiated
- 09/01/2024
- Location
- Sao Paulo, Brazil
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 (US 98, OUS 25)
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.
Product Description
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Distribution Pattern
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.