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U.S. Department of Health and Human Services

Class 2 Device Recall Versatex Monofilament Mesh 50 x 50 cm

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  Class 2 Device Recall Versatex Monofilament Mesh 50 x 50 cm see related information
Date Initiated by Firm February 23, 2018
Date Posted April 26, 2018
Recall Status1 Open3, Classified
Recall Number Z-1523-2018
Recall Event ID 79662
510(K)Number K150091  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M

The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.
Code Information UDI - 10884521532298  Lots SPC1091X SPJ0706X SPJ1016X SQA0990X SQI0302X SQJ0443X SQK0319X SRA2188X SRI0548X 
Recalling Firm/
Manufacturer
Sofradim Production
116 avenue de Formans
Trevoux France
For Additional Information Contact Customer Service
800-9629888 Ext. 2
Manufacturer Reason
for Recall
There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.
FDA Determined
Cause 2
Other
Action All consignees were notified via Federal Express or certified mail on February 23, 2018. Customers were advised of the added warning on the product labeling. Customers were requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. Customers with questions were directed to contact their Medtronic Representative, or Customer Service at 800-962-9888, option 2.
Quantity in Commerce 703
Distribution Worldwide Distribution - USA (nationwide) Distribution to the states of: CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, PA, TN, TX, VA, WA and WI, and to the countries of : Belgium, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Russian Federation, Spain, Switzerland, and UK.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = SOFRADIM PRODUCTION
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