Sofsilk Suture

• • Ongoing Z-1697-2024 FDA Class II ·initiated 25 Jan 2024

  One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.

• • Ongoing Z-0845-2024 FDA Class II ·initiated 21 Dec 2023

  Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

• • Ongoing Z-1176-2023 FDA Class II ·initiated 2 Dec 2022

  Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

• 10 recalls, same reason

  • Terminated Z-2810-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2813-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2815-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2811-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2818-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2812-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2816-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2814-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2817-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2819-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011

  Potential for the sterile barrier to be breached compromising the sterility of the product

510(k) Number

K981128 ↗

FDA Product Code

GAP

Device Class

Class II

Regulation

21 CFR Part 878.5030

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Modified Auto Suture Endoscopic Gia Surg. Stapler*

  Class II

  FDA 510(k) K900129 Active Cleared 27 Feb 1990

• Auto Suture(R) Endoscopic Gia(Tm) Surgical Stapler

  Class II

  FDA 510(k) K892233 Active Cleared 28 Apr 1989

• Caprosyn Absorbable Suture

  Class II

  FDA 510(k) K032586 Active Cleared 17 Nov 2003

• Auto Suture Disposable Gia Surg. Stapler

  Class I

  FDA 510(k) K801590 Active Cleared 4 Aug 1980

• Endoscope Suture & Carrier

  Class II

  FDA 510(k) K912973 Active Cleared 27 Sep 1991

• Modified Surgiport Disposable Trocar and Sleeve

  Class I

  FDA 510(k) K903419 Active Cleared 9 Aug 1990

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