Z-1478-2017 Class II Terminated
FDA device recall Z-1478-2017 was initiated by Inion Ltd. on March 1, 2017 and is designated Class II. Reason for recall: Aluminum pouch seal was noticed to be defective (slightly open). The recall status is terminated (terminated December 18, 2017). Affected quantity: 36 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- March 1, 2017
- Termination Date
- December 18, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 pieces
Product 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.
Reason for Recall
Aluminum pouch seal was noticed to be defective (slightly open).
Distribution Pattern
US Distribution to : FL and NC.
Code Information
Lot Number 1604006, 1505007, 1503039