Home › Device types › NEW
Suture, Surgical, Absorbable, Polydioxanone
FDA product code NEW · Class 2 · General, Plastic Surgery
3,479
Registered devices
15,865
Adverse events
40
Recalls
65
510(k) clearances
Devices with this code
Monoplus — B BRAUN SURGICAL SAOasis — American Health Service Sales CorporationMonoplus — B BRAUN SURGICAL SADemeDIOX — Demetech CorporationDemeDIOX — Demetech CorporationRejubeau Stylish FCL Forte Fix 19G x 100mm (L-shape) — Feeltech Co.,Ltd.VIOLA — MEDITIME CO., LTD.2de12 3-0 Pdo 3.5 X 3.5 — Surgical Specialties México, S. de R.L. de C.V.DemeDIOX — Demetech CorporationPDS — ETHICON, LLCWEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies Inc., Ltd.eXact Suture 3-0 PDO — Cypris Medical, Inc.AMI Custom Crafted FCN | 21G x 90mm — Feeltech Co.,Ltd.DemeDIOX — Demetech CorporationDemeDIOX — Demetech CorporationDemeDIOX — Demetech CorporationWEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies Inc., Ltd.DemeDIOX — Demetech CorporationMonoplus — B BRAUN SURGICAL SASTRATAFIX — ETHICON, LLCMonoplus — B BRAUN SURGICAL SADemeDIOX — Demetech CorporationPDS — ETHICON, LLC2t8 -2- Pdo 14 X 14 — Surgical Specialties México, S. de R.L. de C.V.
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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