Suture, Absorbable, Synthetic, Polyglycolic Acid
General, Plastic Surgery · 21 CFR 878.4493
Recent MDR events
56,265 adverse event reports on file
- VICRYLJul 31, 2026InjuryEthicon Inc.2210968-2026-07657
- VICRYL RAPIDEJul 31, 2026InjuryEthicon Inc.2210968-2026-07658
- PolysorbJul 31, 2026MalfunctionCovidien Surgical1219930-2026-04734
- PolysorbJul 31, 2026MalfunctionCovidien Surgical1219930-2026-04735
- PolysorbJul 31, 2026MalfunctionCovidien Surgical1219930-2026-04736
- NOVOSYNJul 31, 2026InjuryB. Braun Surgical, S.a.3003639970-2026-00676
- NOVOSYNJul 31, 2026InjuryB. Braun Surgical, S.a.3003639970-2026-00678
- NOVOSYNJul 31, 2026InjuryB. Braun Surgical, S.a.3003639970-2026-00681
- NOVOSYNJul 31, 2026InjuryB. Braun Surgical, S.a.3003639970-2026-00677
- NOVOSYNJul 31, 2026InjuryB. Braun Surgical, S.a.3003639970-2026-00679
Event type breakdown
Recalls
130 recall events for this product code
- Covidien, LPOpen, ClassifiedAug 7, 2026
V-Loc 90 Absorbable Wound Closure Device
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 infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Z-2918-2026 · View FDA record ↗ - Covidien, LPOpen, ClassifiedAug 7, 2026
V-Loc 180 Absorbable Wound Closure Device
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 infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Z-2919-2026 · View FDA record ↗ - Ethicon, Inc.Open, ClassifiedNov 7, 2024
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
Z-0319-2025 · View FDA record ↗ - Ethicon, Inc.Open, ClassifiedJun 14, 2024
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use i
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Z-2144-2024 · View FDA record ↗ - Ethicon, Inc.Open, ClassifiedJun 14, 2024
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascul
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Z-2145-2024 · View FDA record ↗ - Ethicon, Inc.Open, ClassifiedJun 14, 2024
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Z-2146-2024 · View FDA record ↗ - Ethicon, Inc.Open, ClassifiedJun 14, 2024
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is i
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Z-2149-2024 · View FDA record ↗ - Ethicon, Inc.Open, ClassifiedApr 12, 2024
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM-
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Z-1533-2024 · View FDA record ↗ - SURGICAL SPECIALTIESOpen, ClassifiedApr 12, 2024
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Complaints have been received with allegations of Incorrect Needle Curvature.
Z-1534-2024 · View FDA record ↗ - Covidien, LPOpen, ClassifiedNov 11, 2022
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated s
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.
Z-0200-2023 · View FDA record ↗
Registered firms
439 firms currently registered for this product code
Covidien
North Haven, CT, US
Resorba Medical Gmbh
NUERNBERG Bavaria, DE
Ethicon, Inc.
CIUDAD JUAREZ Chihuahua, MX
Sterigenics Us Llc
Grand Prairie, TX, US
Peters Surgical International Co., Ltd
Bangkok Krung Thep Maha Nakhon, TH
Sterigenics U.s., Llc
Atlanta, GA, US
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Riverpoint Medical Llc
Portland, OR, US
Kollsut International Inc
North Miami Beach, FL, US
Ad Supply Group Limited
London London, City of, GB
Dylan Lucas International Inc
Vaughan Ontario, CA
Process For Prf Sarl
Nice Alpes-Maritimes, FR
Covidien
- Santo Domingo, DO
Teleflex Medical Llc
Morrisville, NC, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Ethicon, Inc.
SAN ANGELO, TX, US
Sterigenics U.s., Llc
Haw River, NC, US
Mainline Medical Dental Supply
North York Ontario, CA
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Durastat
Austin, TX, US
510(k) clearances
149 clearances for this product code
- ETHICON, Inc.Jun 25, 2026
K253394 · Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
- MedtronicMay 28, 2026
K253530 · Trexon Monofilament Synthetic Absorbable Suture
- ETHICON, Inc.Feb 6, 2026
K253852 · MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
- ETHICON, Inc.Dec 22, 2025
K252743 · STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- Gordian Surgical, Ltd.Dec 16, 2025
K253620 · TroClose 1200
- Internacional Farmacéutica S.A DE C.VOct 3, 2025
K252820 · PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
- Peters SurgicalOct 11, 2024
K233265 · Monotime and Optime R
- Peters SurgicalJul 12, 2024
K232372 · Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)