Reported May 2, 2018 · Terminated
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional…
Sofradim Production
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sofradim Production · 116 avenue de Formans · Trevoux, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- UDI - 10884521532298 Lots
SPC1091XSPJ0706XSPJ1016XSQA0990XSQI0302XSQJ0443XSQK0319XSRA2188XSRI0548X
- UDI - 10884521532298 Lots
- Amount recalled
- 703
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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