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

Recall Z-1478-2017 — Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects a

U.S. FDA — Device Enforcement · Finland · 2017-03-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1478-2017
Date of alert: 2017-03-01
Country / jurisdiction: Finland
Risk level: Class II
Risk type: recall
Brand: Inion Ltd.
Product category: device
Product type: Devices

Reported risk: Aluminum pouch seal was noticed to be defective (slightly open).

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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