Smith & Nephew JOURNEY II Tibia Insert Recall: Wrong Size in Box
Smith & Nephew recalls JOURNEY II Tibia Insert Medial Size 7-8 8MM due to mispackaging. The box contains the wrong size (1-2 12MM) instead of the correct size. Consumers should check product details to determine if affected.
Lower-risk recall
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
Contact the company
What happened, in plain English
Smith & Nephew is recalling a specific size of Tibia Insert due to a manufacturing error that caused the wrong size to be shipped. This could lead to improper use if the incorrect size is installed. Read more at govinfonow.com/recall/58645-smith-nephew-journey-ii-tibia-insert-recall-wrong-size-in.
Source Summary by GovInfoNow · govinfonow.com/recall/58645-smith-nephew-journey-ii-tibia-insert-recall-wrong-size-in · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1393-2023
Cite this page
“Smith & Nephew JOURNEY II Tibia Insert Recall: Wrong Size in Box.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/58645-smith-nephew-journey-ii-tibia-insert-recall-wrong-size-in. Based on FDA recall #Z-1393-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1393-2023%22&limit=1).
Why it’s dangerous
The recall is due to a mispackaging error where the box contains the wrong size (1-2 12MM) instead of the correct size (7-8 8MM). This could cause improper fit if the incorrect size is used in surgery.
Who’s affected
People who purchased the JOURNEY II Tibia Insert Medial Size 7-8 8MM (Catalog Number 740: 74026178) are likely affected. Orthopedic surgeons and patients using this implant are at risk of improper fit.
How to tell if you have this one
Check the product label for the correct size: Medial Size 7-8 8MM. Look for Catalog Number 74026178 and Batch Number 22CAP0038R on the box.
- Brand
Smith & Neph: A short, human brand name for headings (e.g.- Category
Medical device
What to do — step by step
Check Product Details
Verify the product label, catalog number, and batch number to confirm if the item is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
FDA distribution: “US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Maryland, Michigan, Mississippi, New York, Ohio, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 30 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1393-2023 (March 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1393-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.