Recall archive / FDA device enforcement
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 — FDA record Z-0842-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 14, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
- Reason
- 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
- Classification
- Class II
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 92 units Update: 40 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0842-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 6, 2022
- Recall initiation date
- Jan 14, 2022
- Center classification date
- Mar 31, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.