Recall Z-1478-2017— Inion Ltd.

Name: FDA recall Z-1478-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-01

Class II · Terminated

Class II FDA medical device recall by Inion Ltd., initiated 2017-03-01, terminated 2017-12-18. It names one FDA 510(k) clearance: K033074. Product: 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.. Reason: Aluminum pouch seal was noticed to be defective (slightly open)..

Recalling firm: Inion Ltd.
Classification: Class II
Status: Terminated
Initiated: 2017-03-01
Terminated: 2017-12-18
Firm location: FIN-33520 Tampere, N/A, Finland

510(k) clearances named in this recall

1 on FDA's record

K033074 — INION GTR BIODEGRADABLE MEMBRANE SYSTEMInion , Ltd.·cleared 2004-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.