# FDA recall Z-1334-2020

> **Ethicon, Inc.** · Class II · device recall initiated 2019-08-28.

## Product

1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201

## Reason for recall

The product do not meet certain internal testing specifications.

## Distribution

International:  Australia, Hong King, India, Japan, Korea,  Singapore, Thailand

## Key facts

- **Recall number:** Z-1334-2020
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-28
- **Report date:** 2020-02-26
- **Termination date:** 2021-02-11

- **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-1334-2020

## Citation

> AI Analytics. FDA recall Z-1334-2020. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/Z-1334-2020. Source: US FDA. Licensed CC0.

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