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.
FDA Recall Z-1478-2017 · Posted None
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Recalling FirmInion Ltd.
Recall StatusTerminated
Product CodeNPK
Date Initiated2017-03-01
Date Terminated2017-12-18
Product Quantity36 pieces
Reason for Recall
Aluminum pouch seal was noticed to be defective (slightly open).
Firm Action
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.
Root Cause
Other
Distribution Pattern
US Distribution to : FL and NC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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