# FDA recall Z-0002-2019

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2018-06-13.

## Product

JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers:  74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149

## Reason for recall

The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

## Distribution

Worldwide distribution, including US nationwide and Puerto Rico, Austria, United Arab Emirates,  Australia, Belgium, Canada, China, Switzerland, Germany, Denmark, Finland, France, Great Britain, India, Spain, Italy, Netherlands, Portugal, Sweden, Venezuela, South Africa.

## Key facts

- **Recall number:** Z-0002-2019
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-06-13
- **Report date:** 2018-10-10

- **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-0002-2019

## Citation

> AI Analytics. FDA recall Z-0002-2019. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0002-2019. Source: US FDA. Licensed CC0.

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