FDA-Device2017-03-22Class II
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.
Inion Ltd.
Hazard
Aluminum pouch seal was noticed to be defective (slightly open).
Sold states
US Distribution to : FL and NC.
Affected count
36 pieces
Manufactured in
Laakarinkatu 2, N/A, FIN-33520 Tampere, N/A, Finland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1478-2017Don't want to check this manually?
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