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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Flowable Wound Matrix

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  Class 2 Device Recall Integra Flowable Wound Matrix see related information
Date Initiated by Firm March 31, 2019
Create Date May 15, 2019
Recall Status1 Terminated 3 on May 07, 2020
Recall Number Z-1338-2019
Recall Event ID 82653
510(K)Number K072113  
Product Classification Dressing, wound, collagen - Product Code KGN
Product Integra Flowable Wound Matrix
Catalog No: FWD301

Product Usage:
Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.
Code Information Lot Code: 2991332
Recalling Firm/
Manufacturer		 Integra Limited
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Dr. Patricia Kihn
717-309-3966
Manufacturer Reason
for Recall		 Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
FDA Determined
Cause 2		 Under Investigation by firm
Action Integra Lifesciences notified consignees (Hospitals, Distributors and Sales reps) by letter delivered by courier service, facsimile or email on April 1st, 2019. Letter identifies problems, health risk and action to take: review inventory, immediately stop use and return product and complete the Acknowledgment form. Questions Contact Customer Service at 1-800-654-2873 Monday to Friday 8:00 AM  8:00 PM EST or custsvcnj@integralife.com.
Quantity in Commerce 274 units
Distribution Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil
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 = KGN and Original Applicant = INTEGRA LIFESCIENCES CORP.
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