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

Recall date

March 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1478-2017

FDA classification

Class II

Brand / firm

Inion Ltd.

Sold / distributed

US Distribution to : FL and NC.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.