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HERTRA KIT
HERNIAMESH SRL · Model H2T25 · UDI-DI 18032919890259
1
510(k) clearances
170,423
Adverse events (863 deaths)
73
Recalls
141
Facilities
Description
Kit #3 includes a semirigid pre-shaped mesh with hole knitted with Polypropylene monofilament and a tridimensional plug with a round base.The base is made of macroporous mesh, the tip is made of rigid mesh, both knitted with Polypropylene monofilament.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-03 | W.L. Gore & Associates, Inc. | Devices were labeled with an expiration date of four years and ten days rather than the validated two years. |
| 2023-04-25 | Davol, Inc. | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequa |
| 2023-04-25 | Davol, Inc. | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequa |
| 2023-04-25 | Davol, Inc. | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequa |
| 2023-04-25 | Davol, Inc. | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequa |
| 2023-01-11 | Covidien, LP | Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of imp |
| 2022-08-12 | Chamberlain Technologies LLC | Potential presence of residual adhesive material on the mesh surface. |
| 2022-08-12 | Chamberlain Technologies LLC | Potential presence of residual adhesive material on the mesh surface. |
| 2022-08-12 | Chamberlain Technologies LLC | Potential presence of residual adhesive material on the mesh surface. |
| 2022-08-12 | Chamberlain Technologies LLC | Potential presence of residual adhesive material on the mesh surface. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.