Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Check against the official notice below — it lists the full affected range.
Howmedica Osteonics Corp. has recalled Biolox delta Ceramic V40 Femoral Head devices (32mm with +4.0mm offset, catalog number 6570-0-232) due to a potential product mix where the actual size and/or offset of the device inside the package does not match what is printed on the package label. The recall affects 40 units from Lot Number 89546202 that were distributed worldwide, including in numerous U.S. states (Arizona, California, Colorado, Florida, Georgia, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, and Texas) and internationally in Canada, China, Japan, United Kingdom, and the Netherlands.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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. Quantity: 39 units Updated: 40 units Lot/code info: Lot Number: 89546202 GTIN: (01)04546540608536(17)261020(10)89546202
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.