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Prolene EPM8702

by Ethicon Inc. EUDAMEDGUDID

Active European Union Open recall

Ref EPM8702Model PROLENE Suture

Regulatory status

as of 28 Oct 2026

Recall ongoing. 6 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 753191 Date19 Jun 2026IssuedStatusActive expires 19 Jul 2028
United StatesGUDID listing GUDID Number10705031134805 UDI-DIDate31 Jul 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 753191 Active Supplemented

    Technical documentation EU MDR

    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 on shared 510(k) K946173

    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 on shared 510(k) K133356
    • 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.

  • 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 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-1842-2019 FDA Class II initiated 19 Apr 2019 on shared 510(k) K946173
    • Terminated Z-1841-2019 FDA Class II initiated 19 Apr 2019 on shared 510(k) K946173

    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.

  • 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 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.

Specification

EUDAMED · GUDID

Trade Name
Prolene
Generic Name
Polyolefin/fluoropolymer suture, monofilament
Device Name
PROLENE Suture
Model / Ref / Catalog
EPM8702, PROLENE Suture
Primary DI / UDI-DI
10705031134805
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
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Polyolefin/fluoropolymer suture, monofilament

Cleared under the same submission (K133356)

Show all (12)

Cleared under the same submission (K946173)

Show all (12)

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
  • 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