Howmedica Osteonics Corp.: Medical Device Recall in 2022 - (Recall #: Z-0842-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032

Product Classification:

Class II

Date Initiated: January 14, 2022

Date Posted: April 6, 2022

Recall Number: Z-0842-2022

Event ID: 89592

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

Status: Ongoing

Product Quantity: 92 units Update: 40 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated