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U.S. Department of Health and Human Services

Class 2 Device Recall DuraGen XS" Dural Regeneration Matrix

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  Class 2 Device Recall DuraGen XS" Dural Regeneration Matrix see related information
Date Initiated by Firm September 29, 2010
Date Posted November 24, 2010
Recall Status1 Terminated 3 on April 23, 2012
Recall Number Z-0450-2011
Recall Event ID 56912
510(K)Number K072207  
Product Classification Methyl methacrylate for cranioplasty - Product Code GXQ
Product DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA
DuraGen XS is indicated as a dural substitute for repair of dura matter
Code Information Catalog number DXM1022, Lot number 1101586.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Nicole Carmon
609-936-6947
Manufacturer Reason
for Recall		 Test results no longer support a 3 year shelf life.
FDA Determined
Cause 2		 Other
Action Integra LifeSciences Corporation sent an URGENT Product Recall Notification letter dated September 29, 2010, to all affected customers. Integra NeruoSpecialists were informed of the recall via telephone conference call and recall notification letters sent by e-mail. Letters were also sent to customers by Federal Express with copies of e-mail provided to Interga Neuro Specialists on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine any affected product and contact Integra Customer Service at 1-800-654-2873, select option 5, followed by option 3. Customers were instructed to fill out and return the enclosed "Recall Acknowledgement and Return Form" indicating whether or not they possessed any of the affected product. For any questions related to this recall call 1-800-654-2873 and selection option 1.
Quantity in Commerce 118
Distribution Nationwide Distribution including AK, AL, AZ, CA, CO, DC, DE, FL, GA, HI, IL, IN, LA, MA, MD, ME, MN, MO, MT, NC, ND, NH, NJ, NM, NY, OK, PA, TN, TX, UT, VA, VT, WA, WI, AND WV.
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 = GXQ and Original Applicant = INTEGRA LIFESCIENCES CORP.
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