Device 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.
Z-1478-2017
Product summary
- Firm
- Inion Ltd.
- Event
- Event 76638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 pieces
- Official record key
device-enforcement:Z-1478-2017
Official wording
Reason: Aluminum pouch seal was noticed to be defective (slightly open).
Code information: Lot Number 1604006, 1505007, 1503039
Distribution pattern: US Distribution to : FL and NC.
Derived failure modes
-
Labeling or packaging
pouch seal was noticed to be defective (slightly open