---
title: "PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Co... — FDA record Z-0480-2023 | Is It on Recall"
description: "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 p"
url: https://isitonrecall.com/recall/fda-device-z-0480-2023-pds-ii-polydioxanone-suture-violet-monofilament-27in-0-s-a-ct-1-product-code-z340h-for-use-in-soft-t/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approxi... — FDA record Z-0480-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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
- **Reason**: 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
- **Classification**: Class II
- **Recalling firm**: Ethicon, Inc.
- **Quantity**: 7,560 eaches
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0480-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0480-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 21, 2022
- **Recall initiation date**: Nov 16, 2022
- **Center classification date**: Dec 14, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0480-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Ethicon, Inc. records](https://isitonrecall.com/brand/ethicon-inc/)