FDA Medical Device Recalls (openFDA)
Inion Ltd.: 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.
- Recall number
- Z-1478-2017
- Recalling firm
- Inion Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2017-03-01
- Posted
- not on file
- Terminated
- 2017-12-18
- Reason
- Aluminum pouch seal was noticed to be defective (slightly open).
- 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
- 36 pieces
- Distribution
- US Distribution to : FL and NC.
- Lot, serial or model codes
- Lot Number 1604006, 1505007, 1503039
- 510(k) numbers
- ["K033074"]
- PMA numbers
- not on file
- Product code
- NPK
- Firm FEI
- 3003407235
- Firm city
- Tampere
- Firm state
- not on file
- Firm country
- Finland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28