FDA-Device2022-04-06Class II
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Hazard
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
Sold states
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.
Affected count
92 units Update: 40 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0842-2022More Howmedica Osteonics Corp. recalls
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