Howmedica Osteonics recalls Biolox delta Ceramic V40 Femoral Heads 32/ +4.0mm (Catalog 6570-0-232) due to potential size/offset mismatch with labeling. Affected units may have incorrect dimensions for surgical use.
“Howmedica Osteonics Biolox delta Ceramic V40 Femoral Head Recall: Size Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61259-howmedica-osteonics-biolox-delta-ceramic-v40-femoral-head-recall-size. Based on FDA recall #Z-0843-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0843-2022%22&limit=1).
The FDA announced on Jan. 14, 2022, that Howmedica Osteonics Corp. is recalling Biolox delta Ceramic V40 Femoral Heads due to a potential product mix where the size and offset do not match package labeling. The agency issued recall number Z-0843-2022 for the voluntary Class II action.
How to tell if you have it
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm
Catalog Number: 6570-0-232
Lot Number: 89546202
UPC: 04546540608536
The hazard
According to the FDA, the hazard is a 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. The record provides no information regarding incidents or injuries.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Recent brand recalls include acetabular inserts with UHMWPE material aged over 5 years (July 30, 2026) and Triathlon Baseplate Size 3 units with confusing labeling (May 19, 2026). Other recent recalls of similar products include the MICS3 Angled Sagittal Saw Attachment recall (Feb. 2, 2026), the Straumann GM Helix Dental Implant recall (July 13, 2026), and the Encore Medical EMPOWR 3D Knee Tibial Insert recall (Jan. 5, 2026).
How to tell if you have this one
Check for the catalog number 6570-0-232 on the packaging. The lot number 89546202 and GTIN (01)04546540608536(17)261020(10)89546202 are also associated with this specific batch.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Recall number
Product, codes & lots
Quantity
Z-0842-2022
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032; 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
92 units Update: 40 units
Z-0843-2022
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232; Lot Number: 89546202 GTIN: (01)04546540608536(17)261020(10)89546202
39 units Updated: 40 units
Based on the official FDA remedy
What to do — step by step
Verify Product Labeling
Check the package for the catalog number 6570-0-232 and lot number 89546202 to confirm it matches the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 15 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Georgia, Maryland, Minnesota, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0843-2022 (January 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0843-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.