FDA Device

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.

Hazard

Aluminum pouch seal was noticed to be defective (slightly open).

What You Should Do

Remedy

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.

Products

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
Brand
Inion Ltd. Laakarinkatu 2 FIN-33520 Tampere Finland
UPC
Lot Number 1604006, 1505007, 1503039

Units Affected

36 pieces