# FDA recall Z-1053-2022

> **Ethicon, Inc.** · Class II · device recall initiated 2022-03-24.

## Product

STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

## Reason for recall

Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.

## Distribution

International distribution in the country of China.

## Key facts

- **Recall number:** Z-1053-2022
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-24
- **Report date:** 2022-05-18

- **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-1053-2022

## Citation

> AI Analytics. FDA recall Z-1053-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1053-2022. Source: US FDA. Licensed CC0.

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