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Epikut

Sin Sistema de Implante Nacional S/A · Model ILCM 3513 · UDI-DI 07899995294418

DZE Prescription

510(k) clearances

Adverse events

212

Recalls

327

Facilities

Description

IMPLANTE CM Ø3,5 X 13,0MM

Recalls

Date	Firm	Reason
2026-08-12	Straumann USA LLC	There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
2026-07-16	Straumann USA LLC	Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest
2025-07-30	S.I.N. Implant System Ltda	Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which
2025-05-01	Straumann USA LLC	It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
2025-05-01	Straumann USA LLC	It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
2025-01-10	Nobel Biocare	Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the fin
2024-09-01	SIN SISTEMA DE IMPLANTE NACIONAL S.A	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
2023-04-06	Hiossen Inc.	Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm
2022-07-25	Nobel Biocare	Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
2021-12-17	Nobel Biocare Usa Llc	Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.