Perma-Hand SA66G

• • Ongoing Z-0284-2027 FDA Not yet classified ·initiated 23 Sep 2026 ·on shared 510(k) K946173

  Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.

• • Ongoing Z-0153-2027 FDA Class II ·initiated 8 Sep 2026 ·on shared 510(k) K946173

  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 ·on shared 510(k) K946173

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

• • Ongoing Z-1097-2025 FDA Class II ·initiated 20 Dec 2024 ·on shared 510(k) K946173

  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

  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 ·on shared 510(k) K946173
  • Terminated Z-1842-2019 FDA Class II ·initiated 19 Apr 2019 ·on shared 510(k) K946173

  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

  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 ·on shared 510(k) K946173

  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

  Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.

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

Trade Name

Perma-Hand

Generic Name

Silk suture

Device Name

Silk Sterile Non-Absorbable Surgical Suture

Model / Ref / Catalog

SA66G, Silk Suture

Primary DI / UDI-DI

10705031050105

Basic UDI-DI

0705031a011934W

510(k) Number

K946173 ↗

FDA Product Code

GAP

EMDN Code

H010202020302 Silk without needle

GMDN Term

Silk suture

Device Class

Class III EUDAMED

Class II GUDID

Regulation Number

878.5030

EU market of registration

Belgium

GUDID distribution status

In Commercial Distribution

Category: Silk suture

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  Class III

  CE/MDR MDR 719650 Active Valid to Jul 2028

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See all devices from Ethicon Inc. →