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U.S. Department of Health and Human Services

Class 2 Device Recall Inion GTR Membrane systemTacks

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 Class 2 Device Recall Inion GTR Membrane systemTackssee related information
Date Initiated by FirmMarch 01, 2017
Create DateMarch 16, 2017
Recall Status1 Terminated 3 on December 18, 2017
Recall NumberZ-1478-2017
Recall Event ID 76638
510(K)NumberK033074 
Product Classification Barrier, synthetic, intraoral - Product Code NPK
ProductInion 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.
Code Information Lot Number 1604006, 1505007, 1503039
Recalling Firm/
Manufacturer		 Inion Ltd.
Laakarinkatu 2
FIN-33520 Tampere Finland
For Additional Information ContactUS Agent
954-659-9224
Manufacturer Reason
for Recall		Aluminum pouch seal was noticed to be defective (slightly open).
FDA Determined
Cause 2		Other
ActionInion 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.
Quantity in Commerce36 pieces
DistributionUS Distribution to : FL and NC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NPK
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