The Recall Desk

Manufacturer

Sofradim Production

1 recall in our database name Sofradim Production as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2018-05-02

Of the 1 recalls from Sofradim Production we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-1523-2018·2018-05-02

    Sofradim Versatex Monofilament Mesh Recalled for Hernia Recurrence Reports

    Sofradim Production is recalling Versatex Monofilament Mesh due to patient reports of abdominal hernia recurrence following repair. The firm has updated instructions to warn surgeons about risks in specific procedures.

    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 reinfo
    Category
    Medical Device
    Distribution
    Distributed nationwide