Official recall record
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-09-01
- Country of alert
- Brazil
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 07899995273437
- Brand on record
- SIN SISTEMA DE IMPLANTE NACIONAL S.A
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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