Lower riskMedical device recall · FDA · Published June 19, 2024
Howmedica UNITRAX 43mm Hip Implant Component Recall: Mislabeled Size Risk
Howmedica recalls UNITRAX 43mm hip implant components due to potential size mismatch between packaging and actual device. Affected units include specific catalog numbers and lot numbers. Consumers should verify their product details.
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
Take action
Contact the company
📍Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
“Howmedica UNITRAX 43mm Hip Implant Component Recall: Mislabeled Size Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54787-howmedica-unitrax-43mm-hip-implant-component-recall-mislabeled-size-risk. Based on FDA recall #Z-2370-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2370-2024%22&limit=1).
The FDA announced on June 19, 2024, that Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Component - 43mm due to mislabeled packaging where the label size may not match the device inside. The recall affects 18 units distributed worldwide.
How to tell if you have it
Brand: Howmedica
Product: UNITRAX Endoprosthesis Head Component - 43mm
Catalog Number: 6942-5-043
GTIN/UPC: 07613327032376
Lot Numbers: 5Y1350, LN815R, PV0H60
The hazard
The size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix involves sizes 43mm, 42mm, and 38mm.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls include the Howmedica TRIATHLON Hinge Insert Recall (July 30, 2026), the Howmedica Triathlon Baseplate Size 3 Recall (May 19, 2026), and the Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026). Other recent recalls of similar products include the Straumann GM Helix Implant Recall (Aug. 12, 2026), the Straumann GM Helix Dental Implant Recall (July 13, 2026), and the Straumann Bone Level Tapered Implant May Be Wrong Length - Recall (July 16, 2026).
How to tell if you have this one
Check for the catalog number 6942-5-043 and GTIN 07613327032376 on the packaging. The lot numbers 5Y1350, LN815R, and PV0H60 are also associated with this recall.
Brand
Howmedica
Product
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
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 and the countries of Australia, Hong Kong, and UK.
Recall number
Product, codes & lots
Quantity
Z-2370-2024
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043; GTIN: 07613327032376 Lot Numbers: 5Y1350, LN815R, PV0H60
18 units
Z-2371-2024
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042; GTIN: 07613327032369 Lot Numbers: 4615EX, HE645D, 8A399N
18 units
Z-2372-2024
UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038; GTIN: 07613327032338 Lot Numbers: JT38AD, E94VEV
12 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalog number and lot numbers on the packaging to confirm if your unit is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 35 days 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-2370-2024 (June 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2370-2024 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.