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U.S. Department of Health and Human Services

Class 2 Device Recall INTEGRA NEUROSCIENCESSuture CollarsNon Sterile for Single Use Only

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  Class 2 Device Recall INTEGRA NEUROSCIENCESSuture CollarsNon Sterile for Single Use Only see related information
Date Initiated by Firm November 28, 2011
Date Posted February 16, 2012
Recall Status1 Terminated 3 on October 29, 2013
Recall Number Z-1049-2012
Recall Event ID 60599
510(K)Number K854049  K811288  
Product Classification Shunt, central nervous system and components - Product Code JXG
Product "***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro, NJ***"

Collars for lumbar peritoneal shunt
Code Information 1021597, 1031020, 1071033, 1092906, 1094646, 1100128, 1101134
Recalling Firm/
Manufacturer		 Integra Neurosciences PR, Inc.
Carr 402 Norte Km 1.2
Anasco PR 00610
For Additional Information Contact
787-826-2329
Manufacturer Reason
for Recall		 The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
FDA Determined
Cause 2		 Labeling mix-ups
Action Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.
Quantity in Commerce 63 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
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 = JXG and Original Applicant = AMERICAN HEYER SCHULTE
510(K)s with Product Code = JXG and Original Applicant = AMERICAN V. MUELLER
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