Home › Device types › FTL
Mesh, Surgical, Polymeric
FDA product code FTL · Class 2 · General, Plastic Surgery
0
Registered devices
170,422
Adverse events
73
Recalls
337
510(k) clearances
Devices with this code
RECONIX — Davol Inc.XTAC — PRESERVATION SOLUTIONS INCPerFix — Davol Inc.VENTRALIGHT — Davol Inc.ProGrip — SOFRADIM PRODUCTION4DDOME ® — COUSIN BIOTECHSilicone Sheeting Open Border — BENTEC MEDICAL OPCO, LLCOvitex® PRS — AROA BIOSURGERY LIMITEDC-QUR TACSHIELD — Atrium Medical CorporationOvitex® PRS — AROA BIOSURGERY LIMITEDRestella — AROA BIOSURGERY LIMITEDTrulene Mesh — HEALTHIUM MEDTECH LIMITEDC-QUR TACSHIELD — Atrium Medical CorporationSurgiWrap FROST — MAST BIOSURGERY USA INC.Parietene — SOFRADIM PRODUCTIONSURGIMESH®WN — ASPIDE MEDICALTIGR® Matrix Surgical Mesh — Novus Scientific ABOviTex® Low Profile — AROA BIOSURGERY LIMITEDOviTex® 1S — AROA BIOSURGERY LIMITEDE-PACK — Ethicon Inc.E-PACK — Ethicon Inc.E-PACK — Ethicon Inc.Parietex — SOFRADIM PRODUCTIONDynaMesh — FEG Textiltechnik Forschungs- und Entwicklungsges. mbH
Recent 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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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