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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Cranial Access Kits

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  Class 2 Device Recall Integra Cranial Access Kits see related information
Date Initiated by Firm August 24, 2016
Date Posted September 02, 2016
Recall Status1 Terminated 3 on March 30, 2017
Recall Number Z-2733-2016
Recall Event ID 75028
510(K)Number K961113  
Product Classification Drills, burrs, trephines & accessories (manual) - Product Code HBG
Product Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Code Information Lot W1605101: Exp 2016-12 Lot W1605103: Exp 2016-11 Lot W1605106: Exp 2016-11 Lot W1606063: Exp 2016-12 Lot W1605101: Exp 2016-12 W1605103: 2016-11 W1605106: 2016-11 W1606063: 2016-12 
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. d.b.a. Integra Pain Management
3498 W 2400 S Ste 1050
Salt Lake City UT 84119-1135
For Additional Information Contact Dr. Patricia W. Kihn
717-309-3966
Manufacturer Reason
for Recall		 Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.
FDA Determined
Cause 2		 Packaging
Action Consignees notified on August 12, 2016 via letter to identify and return product.
Quantity in Commerce 710
Distribution Nationwide and VA/govt/military. No foreign consignees.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HBG and Original Applicant = CLINICAL NEURO SYSTEMS LLC.
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