Implant Epikut S Plus CM 16-Degrees 4 — Class II medical device recall Z-0920-2025
Ongoing recall by SIN SISTEMA DE IMPLANTE NACIONAL S.A, reported 2025-01-22, distributed in CA, CO, FL, ID, IL, KY, NJ, NY…. Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels t
| Recall number | Z-0920-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SIN SISTEMA DE IMPLANTE NACIONAL S.A, Sao Paulo, Brazil |
| Recall initiated | 2024-09-01 |
| Classified | 2025-01-15 |
| Reported by FDA | 2025-01-22 |
| Distributed | CA, CO, FL, ID, IL, KY, NJ, NY, OH, TX |
| Countries outside the US | BR |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07899995273437 |
| Lot numbers | 2028/01, X010469757 |
| Model numbers | 4518N |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0920-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.