Home › Device types › GAP
Suture, Nonabsorbable, Silk
FDA product code GAP · Class 2 · General, Plastic Surgery
3,821
Registered devices
3,977
Adverse events
28
Recalls
41
510(k) clearances
Devices with this code
Silkam — B BRAUN SURGICAL SADemeSILK — Demetech CorporationSilkam — B BRAUN SURGICAL SAWEGO-SILK Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies Inc., Ltd.HAVEL'S — Havel's IncorporatedSilkam — B BRAUN SURGICAL SAArthrex® — ARTHREX, INC.DemeSILK — Demetech CorporationDemeSILK — Demetech CorporationWEGO-SILK Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies Inc., Ltd.Silkam — B BRAUN SURGICAL SAMANI Sutures Silk — MANI, INC.DemeSILK — Demetech CorporationDemeSILK — Demetech CorporationWEGO-SILK Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies Inc., Ltd.PERMA-HAND — ETHICON, LLCDemeSILK — Demetech Corporation2dsm7 7-0 Bbs 18"/45 Cm — Surgical Specialties México, S. de R.L. de C.V.WEGO-SILK Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies Inc., Ltd.Silkam — B BRAUN SURGICAL SASofsilk — Covidien LPDs24 2-0 Bbs 18"/45 Cm — Surgical Specialties México, S. de R.L. de C.V.Onatec — Surgical Specialties México, S. de R.L. de C.V.DemeSILK — Demetech Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-25 | Covidien, LP | One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutur |
| 2023-12-21 | Covidien LP | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2020-06-10 | Ethicon, Inc. | Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years |
| 2018-12-18 | Ethicon, Inc. | The sutures inside the packaging are not the same size or type as indicated on the label. |
| 2014-10-17 | Ethicon, Inc. | Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products. |
| 2014-03-11 | Teleflex Medical | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. |
| 2011-06-03 | Covidien LP | Potential for the sterile barrier to be breached compromising the sterility of the product |
| 2011-06-03 | Covidien LP | Potential for the sterile barrier to be breached compromising the sterility of the product |
| 2011-06-03 | Covidien LP | Potential for the sterile barrier to be breached compromising the sterility of the product |
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