# FDA recall Z-1393-2023

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2023-03-27.

## Product

JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

## Reason for recall

A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

## Distribution

US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.

## Key facts

- **Recall number:** Z-1393-2023
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-27
- **Report date:** 2023-04-26

- **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-1393-2023

## Citation

> AI Analytics. FDA recall Z-1393-2023. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1393-2023. Source: US FDA. Licensed CC0.

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