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
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