Suture, Absorbable, Natural
General, Plastic Surgery · 21 CFR 878.4830
Recent MDR events
2,489 adverse event reports on file
- ETHICONJul 27, 2026MalfunctionEthicon Inc.2210968-2026-07420
- ETHICONJul 27, 2026MalfunctionEthicon Inc.2210968-2026-07423
- GUT PlainJul 27, 2026InjuryEthicon Inc.2210968-2026-07460
- ETHICONJul 27, 2026MalfunctionEthicon Inc.2210968-2026-07466
- GYNECARE GYNEMESHJul 17, 2026InjuryEthicon Inc.2210968-2026-07289
- ETHILONJul 2, 2026MalfunctionEthicon Inc.2210968-2026-06963
- ETHICONJun 30, 2026MalfunctionEthicon Inc.2210968-2026-06863
- ETHICONJun 30, 2026MalfunctionEthicon Inc.2210968-2026-06865
- ETHICONJun 30, 2026MalfunctionEthicon Inc.2210968-2026-06864
- ETHICONJun 30, 2026MalfunctionEthicon Inc.2210968-2026-06872
Event type breakdown
Recalls
5 recall events for this product code
- Covidien, LPOpen, ClassifiedApr 12, 2023
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
Z-1388-2023 · View FDA record ↗ - Covidien, LPOpen, ClassifiedApr 12, 2023
Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
Z-1389-2023 · View FDA record ↗ - Covidien, LPOpen, ClassifiedApr 12, 2023
Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
Z-1390-2023 · View FDA record ↗ - Ethicon, Inc.TerminatedJun 25, 2015
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp
Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
Z-1839-2015 · View FDA record ↗ - CP Medical IncOpen, ClassifiedUnknown
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box.
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Z-1027-2019 · View FDA record ↗
Registered firms
96 firms currently registered for this product code
Sterigenics Us Llc
Grand Prairie, TX, US
United Medical Industries Co. Ltd.
RIYADH Ar Riyad, SA
Covidien
North Haven, CT, US
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi
Istanbul, TR
Arrow International C.r. A.s.
ZDAR NAD SAZAVOU Vysocina, CZ
Mainline Medical Dental Supply
North York Ontario, CA
Ethicon, Llc.
San Lorenzo, PR, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Healthium Medtech Limited
BANGALORE Karnataka, IN
Riverpoint Medical Cr S.r.l.
Coyol Alajuela, CR
Pronorth Medical
ABBOTSFORD British Columbia, CA
Ethicon, Inc.
CIUDAD JUAREZ Chihuahua, MX
Worldwide Supplies Limited
Hong Kong, HK
Salvin Dental Specialties, Llc
CHARLOTTE, NC, US
Ethicon, Inc.
Somerville, NJ, US
Sterigenics U.s. Llc
MULBERRY, FL, US
Veenak International Limited
BIRMINGHAM, GB
Ethicon, Inc.
Raritan, NJ, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Oketz Logistics Llc
Coral Gables, FL, US
Isomedix Operations, Inc
ONTARIO, CA, US
510(k) clearances
30 clearances for this product code
- CovidienJan 29, 2015
K142656 · Surgical Gut Suture
- Demetech Corp.Apr 30, 2008
K072930 · DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
- United Medical Industries Co. , Ltd.Sep 7, 2005
K042287 · UNIPLAIN & UNICHROM
- Ethicon Endo-Surgery, Inc.Nov 19, 2004
K042897 · AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
- Suturtek IncorporatedMar 17, 2003
K030227 · SUTURTEK FASTCLOSE SUTURING DEVICE
- Serral, S.A. DE C.V.Aug 14, 2002
K020597 · SERRALGUT
- Gramsmed, LLCJun 21, 2002
K021043 · GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
- Qrc ConsultingMay 30, 2001
K011105 · SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE