SIN SISTEMA DE IMPLANTE NACIONAL recalls Implant Epikut S Plus CM 16-Degrees with incorrect diameter labeling. Using the wrong size may cause implant to become loose, requiring additional surgery.
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.
SIN SISTEMA DE IMPLANTE NACIONAL recalled dental implants labeled as 4.5 x 18.0 mm but actually 4.0 x 18.0 mm. If dentists drill with the larger size, the implant may become loose and need extra surgery.
The implant box incorrectly states a diameter of 4.5 x 18.0 mm, but the internal label shows 4.0 x 18.0 mm. If the dentist drills using the larger size from the box, the smaller implant may become loose and require additional surgery.
Dentists using the recalled implant and patients who may need surgery if the implant becomes loose.
Check for the implant model: Epikut S Plus CM 16-Degrees, REF: ILM 4518N. Look for UDI-DI: 07899995273437 and Lot: X010469757 with expiration 2028/01.
Verify the internal label shows 4.0 x 18.0 mm, not 4.5 x 18.0 mm.
The implant box incorrectly labels the diameter as 4.5 x 18.0 mm, but the internal label correctly shows 4.0 x 18.0 mm. Using the larger size may cause the implant to become loose.
The official recall record does not specify actions for dentists.
Check for the model: Epikut S Plus CM 16-Degrees, REF: ILM 4518N, UDI-DI: 07899995273437, Lot: X010469757, expiring 2028/01.
We’ve drafted a message you can send SIN SISTEMA DE IMPLANTE NACIONAL to request your refund or repair — edit it as you like.
Subject: Recall Z-0920-2025 — SIN SISTEMA DE IMPLANTE NACIONAL SIN SISTEMA DE IMPLANTE NACIONAL Hello, I own a SIN SISTEMA DE IMPLANTE NACIONAL that is covered by recall Z-0920-2025 from SIN SISTEMA DE IMPLANTE NACIONAL. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
