Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Reported: January 22, 2025 Initiated: September 1, 2024 #Z-0920-2025
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.
Details
- Recalling Firm
- SIN SISTEMA DE IMPLANTE NACIONAL S.A
- Units Affected
- 123 (US 98, OUS 25)
- Distribution
- US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
- Location
- Sao Paulo
Frequently Asked Questions
What product was recalled? ▼
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N. Recalled by SIN SISTEMA DE IMPLANTE NACIONAL S.A. Units affected: 123 (US 98, OUS 25).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0920-2025.
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