Ethicon, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0480-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery

Product Classification:

Class II

Date Initiated: November 16, 2022

Date Posted: December 21, 2022

Recall Number: Z-0480-2023

Event ID: 91192

Reason for Recall:

knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage

Status: Ongoing

Product Quantity: 7,560 eaches

Code Information:

UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027

Distribution Pattern:

International (OUS) only: Canada, Japan, Australia and New Zealand

Voluntary or Mandated:

Voluntary: Firm initiated