# FDA recall Z-0047-2020

> **Ethicon, Inc.** · Class II · device recall initiated 2019-08-13.

## Product

STRATAFIX Spiral PDS Plus Violet 18  (45cm) CT-1 Needle  Product code: SXPP1B430  suture

## Reason for recall

The product does not meet certain internal strength testing specifications.

## Distribution

States:  IN  MD  AR  IL  GA  TN  NJ  PA  NC  CA  OK  CO  KS  UT  KY  WA  OH  OR    OUS:  Australia  Hong King  India  Japan  Korea  Singapore  Thailand  United States

## Key facts

- **Recall number:** Z-0047-2020
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-13
- **Report date:** 2019-10-16
- **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-0047-2020

## Citation

> AI Analytics. FDA recall Z-0047-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0047-2020. Source: US FDA. Licensed CC0.

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