Perma-Hand C084D

• EUDAMED Basic UDI-DI B-USMF000013112000210K6 registered 15 Sep 2026 Active
• FDA 510(k) K946173 decided 9 Jan 1995 Active
• FDA GUDID UDI-DI D-USMF000013112000210K6 listed 1 Sep 2015 Listed

• • 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.

1. 1 Sep 2015 Listed FDA GUDID D-USMF000013112000210K6
2. 18 Dec 2018 Recall initiated FDA recalls Z-0747-2019
3. 19 Apr 2019 Recall initiated FDA recalls Z-1841-2019
4. 19 Apr 2019 Recall initiated FDA recalls Z-1842-2019
5. 10 Jun 2020 Recall initiated FDA recalls Z-2486-2020
6. 20 Dec 2024 Recall initiated FDA recalls Z-1097-2025
7. 7 Mar 2025 Recall initiated FDA recalls Z-1516-2025
8. 8 Sep 2026 Recall initiated FDA recalls Z-0153-2027
9. 15 Sep 2026 Registered EUDAMED B-USMF000013112000210K6
10. 23 Sep 2026 Recall initiated FDA recalls Z-0284-2027

3 earlier events are in the sections above.

Trade name

Perma-Hand

Generic name

Silk suture

Model / Ref / Catalog

C084D

Primary DI / UDI-DI

D-USMF000013112000210K6 EUDAMED

10705031023680 GUDID

Basic UDI-DI

B-USMF000013112000210K6

510(k) Number

K946173 ↗

FDA product code

GAP

EMDN code

H010202020301 Silk with needle

GMDN term

Silk suture

Device class

Class III EUDAMED

Class II GUDID

Regulation number

878.5030

EU registration type

Legacy device (under a directive)

EU market of registration

Belgium

GUDID distribution status

In Commercial Distribution

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-USMF000013112000210K6; FDA GUDID lists 10705031023680), so their flags are not compared. Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Silk suture

Other devices filed under SILK WITH NEEDLE.

• Silkus TI/C-BRO/01 by TI Medical Private Limited
• MANI SUTURES SILK - 4-0 SILK 25 by MANI, INC.
• Silk 63554-SL by Assut Medical Sàrl
• MANI SUTURES SILK - 6-0 SILK 34 by MANI, INC.
• Silk 6246 by Assut Medical Sàrl
• DemeSILK SK163019F4P by DemeTECH Corp
• DemeSILK SK263017F6PW by DemeTECH Corp
• TRUSILK 5F75DZF26-12 by HEALTHIUM MEDTECH LIMITED

• Stratafix SXPN1B402

  Class II

  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

• Stratafix SXPN1B413

  Class II

  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

• Stratafix SXPN1B409

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  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

• Stratafix SXPN1B403

  Class II

  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

See all devices from Ethicon Inc. →