Home › Device types › GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
FDA product code GAW · Class 2 · General, Plastic Surgery
7,894
Registered devices
19,686
Adverse events
28
Recalls
85
510(k) clearances
Devices with this code
PROLENE — ETHICON, LLCSurgipro II — Covidien LPPROLENE — ETHICON, LLCPRONOVA — ETHICON, LLCOptilene — B BRAUN SURGICAL SADemeLENE — Demetech CorporationDemeLENE — Demetech CorporationRELI® — MYCO MEDICAL SUPPLIES INC.Surgipro ll — Covidien LPDemeLENE — Demetech CorporationATRAMAT — Internacional Farmacéutica, S.A. de C.V.DemeLENE — Demetech CorporationOptilene — B BRAUN SURGICAL SAOptilene — B BRAUN SURGICAL SAOptilene — B BRAUN SURGICAL SADemeLENE — Demetech CorporationOptilene — B BRAUN SURGICAL SACOROLENE® — PETERS SURGICALDemeLENE — Demetech CorporationSurgipro II — Covidien LPDemeLENE — Demetech CorporationDemeLENE — Demetech CorporationOptilene — B BRAUN SURGICAL SASurgipro ll — Covidien LP
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to |
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in s |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in s |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in s |
| 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 |
| 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 |
| 2018-05-07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has t |
| 2018-05-07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has t |
| 2018-05-07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has t |
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