PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: April 6, 2022 Initiated: January 14, 2022 #Z-0843-2022

Product Description

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

Details

Recalling Firm
Howmedica Osteonics Corp.
Units Affected
39 units Updated: 40 units
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.
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232. Recalled by Howmedica Osteonics Corp.. Units affected: 39 units Updated: 40 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on April 6, 2022. Severity: Moderate. Recall number: Z-0843-2022.