Skip to content

Stainless Steel

by Ethicon, LLC United States EUDAMEDGUDID

Ref M656GModel Stainless Steel Suture

Product code GAQEMDN H010202010101

Regulatory status

as of 24 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705031a012654W Basic UDI-DIDate14 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705031045507 UDI-DIDate1 Sep 2015ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

9 recalls · 4 ongoing · FDA

    • Ongoing Z-0153-2027 FDA Not yet classified 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 via K946173, on the same 510(k)

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

    • Ongoing Z-1097-2025 FDA Class II initiated 20 Dec 2024 via K946173, on the same 510(k)

    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 via K946173, on the same 510(k)

    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 via K946173, on the same 510(k)

    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 via K946173, on the same 510(k)

    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 via K946173, on the same 510(k)

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

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Stainless Steel EUDAMED
Ethicon GUDID
Generic Name
Metallic suture, monofilament
Device Name
Stainless Steel Suture
Model / Ref / Catalog
Stainless Steel Suture, M656G
Primary DI / UDI-DI
10705031045507
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
Market of Registration
Belgium
Commercial Distribution
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.

See all devices from Ethicon Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 99970e31-e64f-4681-a00a-7571a5f9e955 61 fields · synced 22 Oct 2026
  • FDA UDI fb9fab29-a852-4940-9240-bfe35c90e4c3 36 fields · synced 30 May 2026