Recall Z-1523-2018— Sofradim Production
Class II · Terminated
Class II FDA medical device recall by Sofradim Production, initiated 2018-02-23, terminated 2020-05-12. It names one FDA 510(k) clearance: K150091. 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.. 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..
- Recalling firm
- Sofradim Production
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-23
- Terminated
- 2020-05-12
- Firm location
- Trevoux, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.