# FDA recall Z-0480-2023

> **Ethicon, Inc.** · Class II · device recall initiated 2022-11-16.

## 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 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

## Distribution

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

## Key facts

- **Recall number:** Z-0480-2023
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-16
- **Report date:** 2022-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerville, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0480-2023

## Citation

> AI Analytics. FDA recall Z-0480-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0480-2023. Source: US FDA. Licensed CC0.

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