Inion GRT Tack — Class II medical device recall Z-1478-2017
Terminated recall by Inion Ltd., reported 2017-03-22, distributed in FL, NC. Aluminum pouch seal was noticed to be defective (slightly open).
| Recall number | Z-1478-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inion Ltd., FIN-33520 Tampere, N/A, Finland |
| Recall initiated | 2017-03-01 |
| Classified | 2017-03-16 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2017-12-18 |
| Distributed | FL, NC |
| Quantity | 36 units |
| Reason classes | packaging |
| Lot numbers | 1503039, 1505007, 1604006 |
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 for recall
Aluminum pouch seal was noticed to be defective (slightly open).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1478-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.