Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Check against the official notice below — it lists the full affected range.
Howmedica Osteonics Corp. is recalling Biolox delta Ceramic V40 Femoral Head 32/-4.0mm devices (catalog number 6570-0-032) due to a potential product mix where the size and/or offset of the femoral head inside the package does not match what is printed on the package label. The recall affects 40 units distributed worldwide, including locations in the U.S., Canada, China, Japan, the UK, and the Netherlands. The affected lot number is 89648802.
The source document 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: 92 units Update: 40 units Lot/code info: Lot Numbers: 89648801 89648802 89648803 89648804 89648805 GTIN: 04546540608475 ****UPDATE 3/17/22: Lot Number: 89648802 UDI: " (01)04546540608475(17)261020(10)89648802 Removed from scope of Recall: 89648801 89648803 89648804 89648805
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.