Reported Mar 22, 2017 · Terminated

Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects…

Inion Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Inion Ltd. · Laakarinkatu 2 · FIN-33520 Tampere, N/A · N/A

Is this the product you have?

  • 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 and empty sockets.
Lot codes and dates
    • Lot Number 1604006
    • 1505007
    • 1503039
Amount recalled
36 pieces

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 18, 2017 · Data as of Sep 19, 5:34 PM UTC

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