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Prolene 8661g

by Ethicon Inc. EUDAMEDGUDID

Active European Union and United States

Ref 8661GModel PROLENE Suture

Regulatory status

as of 28 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 753191 Date19 Jun 2026IssuedStatusActive expires 19 Jul 2028
United StatesGUDID listing GUDID Number10705031018587 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 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

21 recalls · 2 ongoing · FDA

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

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

    • Ongoing Z-1096-2025 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.

  • 19 recalls, same reason

    • Terminated Z-2451-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2463-2018 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-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

    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.

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
8661G, PROLENE Suture
Primary DI / UDI-DI
10705031018587
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

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)

Other devices from Ethicon Inc.

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    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