# FDA recall Z-0843-2022

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2022-01-14.

## Product

Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm	 Catalog Number: 6570-0-232

## Reason for recall

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,  MD, MN, NC, NJ, NY, OH, OR, PA, TN, TX and the countries of Canada, China, Japan, Spain, UK, Netherlands, Germany & Belgium.   ***Updated 3/17/22: U.S., Canada, China, Japan, UK, and Netherlands.

## Key facts

- **Recall number:** Z-0843-2022
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-14
- **Report date:** 2022-04-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0843-2022

## Citation

> AI Analytics. FDA recall Z-0843-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0843-2022. Source: US FDA. Licensed CC0.

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