Class 2 Device Recall Versatex Monofilament Mesh 50 x 50 cm

• Date Initiated by Firm: February 23, 2018
• Date Posted: April 26, 2018
• Recall Status: Terminated on May 12, 2020
• 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: 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 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 = FTL