# FDA recall Z-1533-2024

> **Ethicon, Inc.** · Class II · device recall initiated 2024-03-08.

## Product

STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM-  Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.    Product Code: SXMP2B412

## Reason for recall

Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility

## Distribution

CO GA IA MI NJ NY NY PA SC WI

## Key facts

- **Recall number:** Z-1533-2024
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-08
- **Report date:** 2024-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raritan, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1533-2024

## Citation

> AI Analytics. FDA recall Z-1533-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1533-2024. Source: US FDA. Licensed CC0.

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