Recall Z-1478-2017 ยท NPK Barrier, Synthetic, Intraoral
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.
| Date | Mar 1, 2017 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033074 | INION GTR BIODEGRADABLE MEMBRANE SYSTEM Inion , Ltd., Mar 31, 2004 |