PDS Plus Antibacterial Suture

• • Ongoing Z-2147-2024 FDA Class II ·initiated 10 May 2024

  Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

• • Ongoing Z-1571-2023 FDA Class II ·initiated 31 Mar 2023

  Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved

• • Terminated Z-1135-2019 FDA Class II ·initiated 12 Mar 2019

  VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

• 2 recalls, same reason

  • Terminated Z-2533-2018 FDA Class II ·initiated 8 Jun 2018
  • Terminated Z-2532-2018 FDA Class II ·initiated 8 Jun 2018

  Products do not meet a tensile strength specification

• 3 recalls, same reason

  • Terminated Z-1340-2018 FDA Class II ·initiated 10 Jan 2018
  • Terminated Z-1338-2018 FDA Class II ·initiated 10 Jan 2018
  • Terminated Z-1339-2018 FDA Class II ·initiated 10 Jan 2018

  Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.

• • Terminated Z-1314-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009

  Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

510(k) Number

K061037 ↗

FDA Product Code

NEW

FDA applicant

ETHICON, Inc.

Device Class

Class II

Regulation

21 CFR Part 878.4840

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Ethicon Inc. →

• What is the PDS Plus Antibacterial Suture used for?

  The PDS Plus Antibacterial Suture is designed for use in general and plastic surgery procedures. It provides the same handling and performance as traditional PDS sutures while offering antibacterial protection through its triclosan coating to reduce the risk of surgical site infections.

• Is the PDS Plus Antibacterial Suture single-use or reusable?

  The PDS Plus Antibacterial Suture is supplied sterile and is intended for single use only. It should not be reused on multiple patients or procedures to maintain sterility and prevent potential contamination.

• What sizes and models of the PDS Plus Antibacterial Suture are available?

  The PDS Plus Antibacterial Suture is available in various sizes to accommodate different surgical needs. However, it is not recommended for use in neural tissue, adult cardiovascular tissue, microsurgery, or for contact with the cornea or sclera.

• What is the regulatory status of the PDS Plus Antibacterial Suture?

  The PDS Plus Antibacterial Suture has received FDA 510(k) clearance with the product code NEW and is classified as a Class II device. It was determined to be substantially equivalent to predicate devices for general and plastic surgery procedures.