Sofradim recalls Versatex Monofilament Mesh 50x50cm (Product No. VTX5050M) due to reported abdominal hernia recurrence after hernia repair. Affected lots include SPC1091X through SRA2188X.
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.
Sofradim is recalling Versatex Monofilament Mesh 50x50cm (Product No. VTX5050M) because patient reports show hernia recurrences after hernia repairs using this mesh. This risk is specific to Transversus Abdominis Muscle Release (TAR) procedures.
The mesh has been reported to cause abdominal hernia recurrences in patients after hernia repair. This risk is particularly relevant when the mesh is used in Transversus Abdominis Muscle Release (TAR) procedures, where the mesh is placed through the abdominal wall.
Patients who received Versatex Monofilament Mesh 50x50cm (Product No. VTX5050M) for hernia repair during Transversus Abdominis Muscle Release (TAR) procedures are most at risk. Surgeons using this mesh in TAR procedures should be aware of the recurrence risk.
Check for the product name 'Versatex Monofilament Mesh 50x50cm' with Product Number VTX5050M. Affected lots include SPC1091X, SPJ0706X, SPJ1016X, SQA0990X, SQI0302X, SQJ0443X, SQK0319X, SRA2188X, and SRI0548X.
Look for the lot numbers SPC1091X through SRI0548X on the product packaging.
Patient reports of abdominal hernia recurrence following hernia repair using this mesh in Transversus Abdominis Muscle Release (TAR) procedures.
Product No. VTX5050M.
Lots SPC1091X, SPJ0706X, SPJ1016X, SQA0990X, SQI0302X, SQJ0443X, SQK0319X, SRA2188X, and SRI0548X.
We’ve drafted a message you can send Sofradim to request your refund or repair — edit it as you like.
Subject: Recall Z-1523-2018 — Sofradim Sofradim Hello, I own a Sofradim that is covered by recall Z-1523-2018 from Sofradim. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
