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Stainless Steel

by Ethicon, LLC 15 variants

Ref M682GModel Stainless Steel Suture

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

5 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705031a012654W Basic UDI-DI 10705031045538UDI-DIDate14 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705031045538 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

10 recalls · 5 ongoing · FDA

    • Ongoing Z-0284-2027 FDA Not yet classified initiated 23 Sep 2026

    Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.

    • Ongoing Z-0153-2027 FDA Class II initiated 8 Sep 2026

    Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.

    • Ongoing Z-1516-2025 FDA Class II initiated 7 Mar 2025 on shared 510(k) K946173

    Identified curing issues with the silicone during the needles manufacturing process.

    • Ongoing Z-1097-2025 FDA Class II initiated 20 Dec 2024 on shared 510(k) K946173

    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 sterility, could introduce pathogens to the patient and cause infection.

    • Ongoing Z-2486-2020 FDA Class II initiated 10 Jun 2020 on shared 510(k) K946173

    Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years

  • 2 recalls, same reason

    • Terminated Z-1841-2019 FDA Class II initiated 19 Apr 2019
    • Terminated Z-1842-2019 FDA Class II initiated 19 Apr 2019

    Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

    • Terminated Z-0747-2019 FDA Class II initiated 18 Dec 2018 on shared 510(k) K946173

    The sutures inside the packaging are not the same size or type as indicated on the label.

    • Terminated Z-1839-2015 FDA Class II initiated 8 May 2015 on shared 510(k) K946173

    Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.

    • Terminated Z-0492-2015 FDA Class II initiated 17 Oct 2014 on shared 510(k) K946173

    Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Stainless Steel EUDAMED
Ethicon GUDID
Generic Name
Metallic suture, monofilament
Device Name
Stainless Steel Suture
Model / Ref / Catalog
Stainless Steel Suture, M682G
Primary DI / UDI-DI
10705031045538
Basic UDI-DI
0705031a012654W
510(k) Number
FDA Product Code
GAQ
EMDN Code
H010202010101 Stainless steel monofilament with needle
GMDN Term
Metallic suture, monofilament
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4495
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000013112
Authorised representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Other devices from Ethicon Inc.

  • Coated VICRYL

    Class III

  • Prolene

    Class III

  • Perma-Hand

    Class III

  • Nurolon

    Class III

  • Mersilene

    Class III

  • Coated VICRYL

    Class III

See all devices from Ethicon Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No