Mersilene

• • 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.

Generic Name

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

Device Name

Mersilene Tape

MERSILENE Suture

Model / Ref / Catalog

Mersilene Tape, RS21G, RS23G, RS21U, RS22U, D3193, RS22G, MERSILENE, R870H

Primary DI / UDI-DI

10705031085732, 10705031085756, 10705031065512, 10705031065529, 10705031072060, 10705031085749, 10705031104044

Basic UDI-DI

0705031a0199264, 0705031a0199162, 0705031a014495A

510(k) Number

K946173 ↗

FDA Product Code

GAT

EMDN Code

H90020102, H010201020201,H010201020202

GMDN Term

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

Device Class

Class IIb EUDAMED

Class III EUDAMED

Class II GUDID

Regulation Number

878.5000

Market of Registration

Belgium

Commercial Distribution

In Commercial Distribution

MRI Safety

MR Safe

EUDAMED SRN

US-MF-000013111

Authorised representative

Johnson & Johnson Medical GmbH DE-AR-000007712

• Mersilene

  Class III

  CE/MDR

• Prolene

  Class III

  CE/MDR

• Coated VICRYL

  Class III

  CE/MDR

• Perma-Hand

  Class III

  CE/MDR

• Dermabond

  Class IIa

  CE/MDD

• Prolene

  Class III

  CE/MDR

See all devices from Ethicon Inc. →