FDA recall Z-0843-2022

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

Status

Ongoing

Initiation date

2022-01-14

Report date

2022-04-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

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