Recall Z-1478-2017
Inion Ltd. · initiated March 1, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number 1604006, 1505007, 1503039
Reason for recall
Aluminum pouch seal was noticed to be defective (slightly open).
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1478-2017
- Initiated
- March 1, 2017
- Terminated
- December 18, 2017
- Product code
- NPK – Barrier, Synthetic, Intraoral
- Quantity
- 36 pieces
- Distribution
- US Distribution to : FL and NC.
- Recalling firm
- Inion Ltd., Tampere