# FDA recall Z-2534-2018

> **Ethicon, Inc.** · Class II · device recall initiated 2018-06-08.

## Product

PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle   Product Code: Z511G   (GTIN 10705031061347)

## Reason for recall

Products do not meet a tensile strength specification

## Distribution

Japan

## Key facts

- **Recall number:** Z-2534-2018
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-08
- **Report date:** 2018-08-01
- **Termination date:** 2020-09-25

- **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-2534-2018

## Citation

> AI Analytics. FDA recall Z-2534-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2534-2018. Source: US FDA. Licensed CC0.

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