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Suture, Surgical, Absorbable, Polydioxanone
FDA product code NEW · Class 2 · General, Plastic Surgery
0
Registered devices
16,281
Adverse events
40
Recalls
67
510(k) clearances
Devices with this code
DemeDIOX — Demetech CorporationPDS — ETHICON, LLCPDO, Violet, 3-0, 30cm, Taper Point, 1/2 Circle, 26mm, Uni-directional — Surgical Specialties México, S. de R.L. de C.V.DemeDIOX — Demetech CorporationDemeDIOX — Demetech CorporationDemeDIOX — Demetech CorporationDemeDIOX — Demetech CorporationMonoplus — B BRAUN SURGICAL SAASSUFIL MONOFILAMENTO — ASSUT EUROPE SPARENOVATIO — Bonago Medical Solutions LLCPDS — ETHICON, LLCMonoplus — B BRAUN SURGICAL SAPDO Max Threads — Max Pdo IncPDO Max Threads — Max Pdo IncRELI® — MYCO MEDICAL SUPPLIES INC.Monoplus — B BRAUN SURGICAL SAPDS — ETHICON, LLCWEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies Inc., Ltd.DemeDIOX — Demetech CorporationMonoplus — B BRAUN SURGICAL SADemeDIOX — Demetech CorporationPDS — ETHICON, LLCFILBLOC — ASSUT EUROPE SPADemeDIOX — Demetech Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-15 | ETHICON, LLC | Potential for barb non-engagement. |
| 2025-03-07 | Ethicon Endo Surgery, LLC | Identified curing issues with the silicone during the needles manufacturing process. |
| 2025-03-07 | Ethicon Endo Surgery, LLC | Identified curing issues with the silicone during the needles manufacturing process. |
| 2025-03-07 | Ethicon Endo Surgery, LLC | Identified curing issues with the silicone during the needles manufacturing process. |
| 2025-03-07 | Ethicon Endo Surgery, LLC | Identified curing issues with the silicone during the needles manufacturing process. |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2023-08-10 | ETHICON, LLC | Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. |
| 2023-08-10 | ETHICON, LLC | Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. |
| 2023-03-31 | Ethicon, Inc. | Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or |
| 2022-11-16 | Ethicon, Inc. | knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than p |
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