Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
General, Plastic Surgery · 21 CFR 878.4495
Recent MDR events
936 adverse event reports on file
- NON ABSORBABLE SURGICAL SUTUREJul 21, 2026MalfunctionEthicon Inc.2210968-2026-07342
- SURGICAL STAINLESS STEEL SUTUREJul 17, 2026InjuryEthicon Inc.2210968-2026-07284
- SURGICAL STAINLESS STEEL SUTUREJun 30, 2026MalfunctionEthicon Inc.2210968-2026-06900
- SURGICAL STAINLESS STEEL SUTUREJun 30, 2026MalfunctionEthicon Inc.2210968-2026-06902
- SURGICAL STAINLESS STEEL SUTUREJun 30, 2026MalfunctionEthicon Inc.2210968-2026-06903
- SUTURE, NONABSORBABLE, STEELJun 30, 2026MalfunctionEthicon Inc.2210968-2026-06904
- ETHIBOND EXCELJun 26, 2026MalfunctionEthicon Inc.2210968-2026-06715
- ETHIBOND EXCELJun 26, 2026MalfunctionEthicon Inc.2210968-2026-06716
- ETHIBOND EXCELJun 26, 2026MalfunctionEthicon Inc.2210968-2026-06717
- ETHIBOND EXCELJun 26, 2026MalfunctionEthicon Inc.2210968-2026-06719
Event type breakdown
Recalls
6 recall events for this product code
- Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedSep 26, 2022
Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1802-2022 · View FDA record ↗ - Teleflex MedicalTerminatedMay 7, 2014
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polygly
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Z-1557-2014 · View FDA record ↗ - Teleflex MedicalTerminatedMay 7, 2014
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Z-1560-2014 · View FDA record ↗ - Teleflex MedicalTerminatedApr 24, 2014
Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-7
The products are being recalled because they did not meet minimum diameter requirements.
Z-1497-2014 · View FDA record ↗ - Ethicon, Inc.TerminatedUnknown
ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Z-1841-2019 · View FDA record ↗ - Ethicon, Inc.TerminatedUnknown
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Z-1842-2019 · View FDA record ↗
Registered firms
110 firms currently registered for this product code
Kollsut International Inc
North Miami Beach, FL, US
Teleflex Medical Llc
Morrisville, NC, US
Sterigenics Us Llc
Grand Prairie, TX, US
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
Teleflex Llc (nadc)
Olive Branch, MS, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Internacional Farmaceutica, S.a. De C.v.
LERMA Mexico, MX
Teleflex Medical Llc
MANSFIELD, MA, US
Conextions Inc
Salt Lake City, UT, US
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
Sterigenics U.s., Llc
Atlanta, GA, US
Synthes (usa) Products Llc
West Chester, PA, US
Ethicon, Inc.
CIUDAD JUAREZ Chihuahua, MX
Sterigenics U.s., Llc
Corona, CA, US
Worldwide Supplies Limited
Hong Kong, HK
Internacional Farmaceutica, S.a. De C.v.
Mexico City, MX
Ethicon, Inc.
Somerville, NJ, US
Pronorth Medical
ABBOTSFORD British Columbia, CA
510(k) clearances
32 clearances for this product code
- Conextions MedicalApr 22, 2022
K203855 · CoNextions TR Tendon Repair System
- Foosin Medical Supplies Inc., Ltd.Feb 19, 2020
K193209 · Wego-Stainless Steel
- M/s. Meril Endo Surgery Private Limited.Feb 1, 2018
K172146 · MERISTEEL
- ETHICON, Inc.Nov 1, 2017
K170767 · Surgical Stainless Steel Suture, Stainless Steel Suture
- Demetech Corp.Sep 25, 2014
K141007 · DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
- Pontis Orthopaedics, LLCMay 28, 2014
K140127 · FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
- Core Essence Orthopaedics, LLCDec 24, 2008
K081060 · FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
- Suturtek IncorporatedOct 14, 2008
K082828 · SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE