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Ethibond Excel PE7055H

by Ethicon Inc. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 28 Oct 2026

Recall ongoing on a related submission. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705031103085 UDI-DIDate17 Jul 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

9 recalls · 4 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.

    • 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.

    • Ongoing Z-1097-2025 FDA Class II initiated 20 Dec 2024 via K946173, on the same 510(k)

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

    • 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

GUDID

Trade Name
Ethibond Excel
Generic Name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / Ref / Catalog
PE7055H
Primary DI / UDI-DI
10705031103085
510(k) Number
FDA Product Code
GAT
GMDN Term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device Class
Class II
Regulation Number
878.5000
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Safe

Related devices

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 (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