FDA Enforcement
Class II
Ongoing
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Recall: Z-0920-2025
·
Reported January 22, 2025
Enforcement
- Recall Number
- Z-0920-2025
- Event ID
- 95983
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SIN SISTEMA DE IMPLANTE NACIONAL S.A
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 22, 2025
- Initiation Date
- September 1, 2024
- Classification Date
- January 15, 2025
- Address
- Jardim Analia Franco, Rua Soldador Ocimar Guimaraes da Silva 421, Sao Paulo, N/A, Brazil
Description
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Reason
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.
Code Info
UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
Distribution
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Quantity
123 (US 98, OUS 25)