Monofilament Biosyn Suture

• 27 recalls, same reason

  • Terminated Z-1276-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1278-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1279-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1284-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1285-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1297-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1275-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1274-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1288-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1281-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1287-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1292-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1296-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1293-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1300-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1289-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1298-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1299-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1286-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1283-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1280-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1290-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1277-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1295-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1282-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1291-2020 FDA Class II ·initiated 18 Dec 2019
  • Terminated Z-1294-2020 FDA Class II ·initiated 18 Dec 2019

  There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

• • Terminated Z-2544-2017 FDA Class II ·initiated 3 May 2017

  Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

510(k) Number

K000037 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

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

See all devices from United States Surgical, A Division of Tyco Healthc →

• What types of surgical procedures is the Monofilament Biosyn Suture intended for, and why is it preferred in those settings?

  The Monofilament Biosyn Suture is designed for use in general and plastic surgery procedures, where tissue approximation and wound closure require minimal tissue reactivity and sustained strength. Since it is made from polyglycolic acid, an absorbable synthetic material, it provides a smooth, monofilament structure that reduces friction and tissue trauma during suturing, making it ideal for delicate or sensitive tissues.

• Is the Monofilament Biosyn Suture meant for single-use only, and if so, how should it be stored to maintain sterility?

  Yes, the Monofilament Biosyn Suture is supplied in sterile, single-use packaging, ensuring contamination-free use in surgical settings. To preserve sterility, it should be stored in its original, unopened packaging in a cool, dry place, away from direct sunlight or extreme temperatures, until ready for use.

• What size and length variations are available for the Monofilament Biosyn Suture, and how does this affect its clinical application?

  The Monofilament Biosyn Suture is available in multiple sizes and lengths, as indicated by the listed FEI numbers (e.g., 3003495548, 3038718579, etc.), which correspond to different gauges and cutting lengths. These variations allow clinicians to select the appropriate size for specific tissue types and surgical needs, ensuring optimal wound closure and tissue handling in both general and plastic surgery.

• How is the regulatory approval process for this suture structured, and what does it mean for its use in clinical settings?

  The Monofilament Biosyn Suture received FDA 510(k) clearance (K000037) under a traditional review pathway, demonstrating it is substantially equivalent to a legally marketed predicate device. This means it has undergone rigorous evaluation for safety and effectiveness in general and plastic surgery applications, ensuring it meets regulatory standards for absorbable, synthetic sutures before clinical use.