Home › Device types › FTL
Mesh, Surgical, Polymeric
FDA product code FTL · Class 2 · General, Plastic Surgery
1,778
Registered devices
170,077
Adverse events
73
Recalls
336
510(k) clearances
Devices with this code
Parietex — SOFRADIM PRODUCTIONSilicone Silo Bag with Wire Ring Sizer Ring — SPECIALTY SURGICAL PRODUCTS INCETHICON PHYSIOMESH — Johnson & Johnson International Inc.Silicone Blocks — BENTEC MEDICAL OPCO, LLCSEPRAMESH — Davol Inc.GORE-TEX Soft Tissue Patch — W. L. Gore & Associates, Inc.GORE DUALMESH Biomaterial — W. L. Gore & Associates, Inc.Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS INCPROCEED — Johnson & Johnson International Inc.PROLITE — Atrium Medical CorporationSurgiMesh — BG MEDICAL, LLCPhasix — Davol Inc.Parietex — SOFRADIM PRODUCTIONProGrip — SOFRADIM PRODUCTIONParietene DS — SOFRADIM PRODUCTIONE-PACK — Ethicon Inc.VENTRIO — Davol Inc.Symbotex — SOFRADIM PRODUCTIONE-PACK — Ethicon Inc.Parietex — SOFRADIM PRODUCTIONOviTex LPR Reinforced Bioscaffold — AROA BIOSURGERY LIMITEDPROLITE — Atrium Medical CorporationVENTRALIGHT — Davol Inc.Phasix — Davol Inc.
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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