Smith & Nephew JOURNEY II Knee Prosthesis Recall: Mislabeling Risk
Smith & Nephew recalls specific knee prostheses due to mislabeling that could lead to incorrect use. Affected models include JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262. Contact for details.
Lower-risk recall
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
Contact the company
What happened, in plain English
Smith & Nephew is recalling a specific knee prosthesis model due to mislabeling between two similar products. This could lead to using the wrong part, which might cause improper fitting or complications during surgery. Read more at govinfonow.com/recall/57222-smith-nephew-journey-ii-knee-prosthesis-recall-mislabeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/57222-smith-nephew-journey-ii-knee-prosthesis-recall-mislabeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0158-2024
Cite this page
“Smith & Nephew JOURNEY II Knee Prosthesis Recall: Mislabeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57222-smith-nephew-journey-ii-knee-prosthesis-recall-mislabeling-risk. Based on FDA recall #Z-0158-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0158-2024%22&limit=1).
Why it’s dangerous
The prosthesis was mislabeled between two similar products. One was labeled as a constrained insert but packaged as an un-constrained insert, and vice versa. This could lead to using the wrong type of knee implant during surgery, potentially causing improper fitting or complications.
Who’s affected
Patients who received the JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262 knee prosthesis from Smith & Nephew. Surgeons and medical staff who used this model during procedures are most at risk.
How to tell if you have this one
Check for the product name 'JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left' with reference number 74029262. The batch number is 22BM17564 and the UDI/DI code is 00885556176467.
- Brand
Smith & Nephew- Category
Medical device
All 2 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 country of Japan.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0157-2024 | JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis; UDI/DI 00885556178010, Batch Number 22BM18348 | 28 units |
| Z-0158-2024 | JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis; UDI/DI 00885556176467, Batch Number 22BM17564 | 29 units |
What to do — step by step
Check Product Details
Verify the product name, reference number, and batch number to confirm if your knee prosthesis is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the country of Japan.” 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.
- 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-0158-2024 (September 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0158-2024 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.