Z-1478-2017Class II

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

Name: Z-1478-2017 Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal...
Creator: Inion Ltd.
Published: 2017-03-01
License: https://open.fda.gov/license/

Inion Oy / initiated 2017-03-01 / Terminated / root cause: packaging

FDA source

Inion Ltd. began a recall of 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... on 2017-03-01. FDA classified it as Class II and gives the reason as "Aluminum pouch seal was noticed to be defective (slightly open)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1478-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-01
Posted: 2017-03-16
Terminated: 2017-12-18
Recalling firm: Inion Oy
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.
Product code: NPK Barrier, Synthetic, Intraoral
Reason for recall: Aluminum pouch seal was noticed to be defective (slightly open).
Root cause tag: packaging
FDA root cause: Other
Action: Inion sent an Urgent: Medical Device Recall Notification letter dated March 1, 2017. The recall letter asked customers to inspect the aluminum pouch seals, remove any devices with defective seals from sales stock, and to return the product to Inion. The customers were also asked to inform Inion Oy of the outcome of their inspections using a feedback form. For further questions call (954) 659-9224.
Quantity in commerce: 36 pieces
Distribution: US Distribution to : FL and NC.
Product codes and lots: Lot Number 1604006, 1505007, 1503039

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1478-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1478-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-16

Product code NPK

K033074Class IIInion Gtr Biodegradable Membrane SystemInion , Ltd. / cleared 2004-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)