FDA Device recall Z-1478-2017
Inion GRT Tack, drill bit and tack appl., 4x, Sterile
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of Inion GRT Tack, drill bit and tack appl., 4x, Sterile by Inion, citing aluminum pouch seal was noticed to be defective (slightly open).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1478-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-01 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Inion |
| Distribution | FL, NC |
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).
Identifiers
| code_info | Lot Number 1604006, 1505007, 1503039 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1478-2017%22
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