Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0017-2026 — IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, R

U.S. FDA — Device Enforcement · Brazil · 2025-07-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0017-2026
Date of alert: 2025-07-30
Country / jurisdiction: Brazil
Risk level: Class II
Risk type: recall
Brand: S.I.N. Implant System Ltda
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 7899995277558

Reported risk: 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 could compromise product quality and performance.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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