# FDA recall Z-1136-2019

> **Ethicon, Inc.** · Class II · device recall initiated 2019-03-12.

## Product

PDS II SUTURE 18"(45CM) 2-0 VIO  Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable

## Reason for recall

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

## Distribution

Worldwide distributions - US Nationwide and countries of   AUSTRALIA  BELGIUM  CANADA  CHINA  ISRAEL  JAPAN  PUERTO RICO  SINGAPORE

## Key facts

- **Recall number:** Z-1136-2019
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-12
- **Report date:** 2019-04-24
- **Termination date:** 2020-07-17

- **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-1136-2019

## Citation

> AI Analytics. FDA recall Z-1136-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1136-2019. Source: US FDA. Licensed CC0.

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