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SIN SISTEMA DE IMPLANTE NACIONAL S.A
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for SIN SISTEMA DE IMPLANTE NACIONAL S.A and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-01-22FDA-DeviceClass IIImplant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
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.
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