Reported Jan 22, 2025 · Ongoing
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Sin Sistema de Implante Nacional S.a
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SIN SISTEMA DE IMPLANTE NACIONAL S.A · Jardim Analia Franco · Sao Paulo · N/A
Is this the product you have?
Implant Epikut S Plus CM 16-Degrees 45 X 180 mm
- REFILM 4518N
- Lot codes and dates
- UDI-DI07899995273437
- LotX010469757
- Expiration2028/01
- Amount recalled
- 123 (US 98, OUS 25)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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