Recall Z-1523-2018 ยท FTL Mesh, Surgical, Polymeric
Sofradim Production
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.
| Date | Apr 26, 2018 (initiated Feb 23, 2018) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 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, Sw |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150091 | Versatex Monofilament Mesh Sofradim Production, May 26, 2015 |