Device product
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Z-0920-2025
Product summary
- Event
- Event 95983
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 123 (US 98, OUS 25)
- Official record key
device-enforcement:Z-0920-2025
Official wording
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 information: UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
Distribution pattern: US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Derived failure modes
-
Unknown
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.