Versatex Monofilament Mesh 50 x 50cm — Class II medical device recall Z-1523-2018
Terminated recall by Sofradim Production, reported 2018-05-02, distributed nationwide. There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has
| Recall number | Z-1523-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sofradim Production, Trevoux, N/A, France |
| Recall initiated | 2018-02-23 |
| Classified | 2018-04-26 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, ES, FI, FR, GB, IE, IL, IT, NL |
| Quantity | 703 |
| UPC / GTIN / UDI-DI | 10884521532298 |
| Lot numbers | SPC1091X, SPJ0706X, SPJ1016X, SQA0990X, SQI0302X, SQJ0443X, SQK0319X, SRA2188X, SRI0548X |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1523-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.