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Prolene 8529H

by Ethicon Inc. EUDAMEDGUDID

Active European Union Open recall

Ref 8529HModel PROLENE Suture

Regulatory status

as of 28 Oct 2026

Recall ongoing. 2 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 Number10705031091115 UDI-DIDate9 Nov 2017ListedStatusListed 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  • Withdrawn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

21 recalls · 2 ongoing · FDA

    • Ongoing Z-1515-2025 FDA Class II initiated 7 Mar 2025 on shared 510(k) K133356

    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 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
8529H, PROLENE Suture
Primary DI / UDI-DI
10705031091115
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)

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