# FDA recall Z-0989-2020

> **Ethicon, Inc.** · Class II · device recall initiated 2020-01-03.

## Product

Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.

## Reason for recall

Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.

## Distribution

Domestic distribution nationwide. US and Puerto Rico only.

## Key facts

- **Recall number:** Z-0989-2020
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-03
- **Report date:** 2020-02-12
- **Termination date:** 2021-08-13

- **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-0989-2020

## Citation

> AI Analytics. FDA recall Z-0989-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0989-2020. Source: US FDA. Licensed CC0.

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