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.
Recall
- Recall Number
- Z-1478-2017
- Event Number
- 76638
- Firm
- Inion Ltd. Laakarinkatu 2 FIN-33520 Tampere Finland
- FEI Number
- 3003407235
- Product Code
- NPK
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 1, 2017
- Terminated
- December 18, 2017
Description
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.
Aluminum pouch seal was noticed to be defective (slightly open).
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.
US Distribution to : FL and NC.
36 pieces