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
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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.
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510(K) Database |
510(K)s with Product Code = KGN and Original Applicant = INTEGRA LIFESCIENCES CORP.
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