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Coated VICRYL D8878

by Ethicon Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

4 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705031031418 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · 4 ongoing · FDA

    • Ongoing Z-1513-2025 FDA Class II initiated 7 Mar 2025 on shared 510(k) K183183

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

    • Ongoing Z-0319-2025 FDA Class II initiated 25 Sep 2024

    Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.

  • 2 recalls, same reason

    • Ongoing Z-2146-2024 FDA Class II initiated 10 May 2024
    • Ongoing Z-2144-2024 FDA Class II initiated 10 May 2024

    Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

    • Terminated Z-0989-2020 FDA Class II initiated 3 Jan 2020

    Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.

    • Terminated Z-1087-06 FDA Unclassified (pre-2012) initiated 4 May 2006

    Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Coated VICRYL
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Model / Ref / Catalog
D8878
Primary DI / UDI-DI
10705031031418
510(k) Number
FDA Product Code
GAM
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device Class
Class II
Regulation Number
878.4493
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Cleared under the same submission (K022269)

Show all (12)

Cleared under the same submission (K183183)

Show all (12)

Other devices from Ethicon Inc.

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    Class III

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    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 (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No