FDAFDA · Food and drugs·Recall number Z-1478-2017
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.
Published March 22, 2017 · Recall initiated: March 1, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Aluminum pouch seal was noticed to be defective (slightly open).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Inion Ltd.
- Distributor
- US Distribution to : FL and NC.
- Lot
- Lot Number 1604006, 1505007, 1503039
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Finland
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