# FDA recall Z-1135-2019

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

## Product

VICRYL PLUS Sutures:  VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO   VICRYL PLUS SUTURE 18"(45CM) 0 UND  VICRYL PLUS SUTURE 18"(45CM) 0 VIO   VICRYL PLUS SUTURE 18"(45CM) 0 VIO)  VICRYL PLUS SUTURE 18"(45CM) 1 VIO   VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO   VICRYL PLUS SUTURE 27"(70CM) 3-0 VIO   VICRYL PLUS SUTURE 18"(45CM) 2-0 UND   VICRYL PLUS SUTURE 18"(45CM) 1 UND    VICRYL PLUS SUTURE 27"(70CM) 0 UND   VICRYL PLUS SUTURE 27"(70CM) 2-0 UND - Product Usage: Coated VICRYL Suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues

## 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-1135-2019
- **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-1135-2019

## Citation

> AI Analytics. FDA recall Z-1135-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1135-2019. Source: US FDA. Licensed CC0.

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