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U.S. Department of Health and Human Services

Class 2 Device Recall DURAGEN II DURAL REGENERATION MATRIX

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  Class 2 Device Recall DURAGEN II DURAL REGENERATION MATRIX see related information
Date Initiated by Firm January 13, 2010
Date Posted March 11, 2010
Recall Status1 Terminated 3 on March 18, 2010
Recall Number Z-1081-2010
Recall Event ID 54253
510(K)Number K043427  
Product Classification Dura substitute - Product Code GXQ
Product Suturable DuraGen Dural Regeneration Matrix;
Non-Pyrogenic;
Sterility guaranteed unless package is damaged or opened. Rx only.
Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536

Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.
Code Information Catalog Number DURS3391; Lot number 1091575
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact Dana Memesh
609-275-2700
Manufacturer Reason
for Recall		 One lot of Suturable DuraGen Dural Regeneration Matrix (# 1091575) did not pass stability testing at certain time points for Suture Retention Strength and Shrink Temperature specifications.
FDA Determined
Cause 2		 Other
Action An "URGENT PRODUCT RECALL NOTIFICATION" dated January 13, 2010, was sent via Federal Express to customers. The notification described the product, problem, hazard involved and action to be taken by customers. In the event that the customers have in their possession any products from the specific lot number 1091576, the customers are being ask to please immediately quarantine all stock on hand and contact their local Integra Sales representative for further assistance and for arrangements of product return. The customers are being ask to return the enclosed "Recall Acknowledge and Return Form" indicating whether or not they possess any of the affected product identified. Integra will replace any product affected by this Recall that is returned. Please feel free to contact me at 609-936-5407 should you have any additional questions.
Quantity in Commerce 94
Distribution Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.
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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