medical Class II Updated 2025-01-22

SIN SISTEMA DE IMPLANTE NACIONAL S.A recalls Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM

Recalled Product

Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N


Hazard / Issue

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.

Issued by

FDA

Affected States: KY, CO, CA, NY, ID, NJ, FL, TX, IL, OH
Lot/Code Info: UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
View official government recall

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