# FDA recall Z-0158-2024

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2023-09-27.

## Product

JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis

## Reason for recall

The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

## Distribution

Worldwide distribution - US Nationwide and the country of Japan.

## Key facts

- **Recall number:** Z-0158-2024
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-27
- **Report date:** 2023-11-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0158-2024

## Citation

> AI Analytics. FDA recall Z-0158-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0158-2024. Source: US FDA. Licensed CC0.

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