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Prolene EH7583H

by Ethicon Inc. EUDAMEDGUDID

Active European Union and United States

Ref EH7583HModel PROLENE Suture

Regulatory status

as of 27 Oct 2026

Recall ongoing. 6 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705031a012584Z Basic UDI-DIDate15 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705031097230 UDI-DIDate11 Nov 2025ListedStatusIn 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 AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 753191 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    19 Jun 2026
    Expires
    19 Jul 2028
    Reason
    Other

Recalls

30 recalls · 6 ongoing · FDA

    • Ongoing Z-0153-2027 FDA Not yet classified initiated 8 Sep 2026 via K946173, on the same 510(k)

    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.

  • 2 recalls, same reason

    • Ongoing Z-1515-2025 FDA Class II initiated 7 Mar 2025 via K133356, on the same 510(k)
    • 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.

  • 2 recalls, same reason

    • Ongoing Z-1096-2025 FDA Class II initiated 20 Dec 2024
    • Ongoing Z-1097-2025 FDA Class II initiated 20 Dec 2024

    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-1842-2019 FDA Class II initiated 19 Apr 2019 via K946173, on the same 510(k)
    • Terminated Z-1841-2019 FDA Class II initiated 19 Apr 2019 via K946173, on the same 510(k)

    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.

  • 19 recalls, same reason

    • Terminated Z-2455-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2464-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2454-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2456-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2462-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2459-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2461-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2453-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2466-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2458-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2452-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2450-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2449-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2460-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2451-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2465-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2448-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2457-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2463-2018 FDA Class II initiated 7 May 2018

    The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

    • 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

Trade Name
Prolene
Generic Name
Polyolefin/fluoropolymer suture, monofilament
Device Name
PROLENE Suture
Model / Ref / Catalog
EH7583H, PROLENE Suture
Primary DI / UDI-DI
10705031097230
Basic UDI-DI
0705031a012584Z
510(k) Number
FDA Product Code
GAW
EMDN Code
H010201010401,H010201010402
GMDN Term
Polyolefin/fluoropolymer suture, monofilament
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
878.5010
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K133356)

Show all (12)

Cleared under the same submission (K946173)

Show all (12)

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • 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