Z-0920-2025 Class II Ongoing
FDA device recall Z-0920-2025 was initiated by SIN SISTEMA DE IMPLANTE NACIONAL S.A on September 1, 2024 and is designated Class II. 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 stat… The recall status is ongoing. Affected quantity: 123 (US 98, OUS 25).
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- September 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 (US 98, OUS 25)
Product Description
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
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.
Distribution Pattern
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Code Information
UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01