Smith & Neph: Recalled Knee Implant Due to Wrong Size in Package
Smith & Nephew recalls a specific knee implant model that was shipped with the wrong size (size 4 left) instead of size 3 left. This could lead to improper fitting and complications during surgery.
Lower-risk recall
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Contact the company
What happened, in plain English
Smith & Nephew has recalled a specific knee implant model because it was shipped with the wrong size (size 4 left) instead of size 3 left. Using this incorrect implant could cause improper fitting and surgical complications. Read more at govinfonow.com/recall/53835-smith-neph-recalled-knee-implant-due-to-wrong-size-in.
Source Summary by GovInfoNow · govinfonow.com/recall/53835-smith-neph-recalled-knee-implant-due-to-wrong-size-in · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0278-2025
Cite this page
“Smith & Neph: Recalled Knee Implant Due to Wrong Size in Package.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53835-smith-neph-recalled-knee-implant-due-to-wrong-size-in. Based on FDA recall #Z-0278-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0278-2025%22&limit=1).
Why it’s dangerous
The implant was shipped with the wrong size (size 4 left) instead of size 3 left as labeled. This mismatch could lead to improper fitting during surgery, potentially causing complications.
Who’s affected
Patients who received this specific knee implant model (size 4 left) from Smith & Nephew are affected. Those who had surgery using this incorrect implant may be at risk of improper fitting.
How to tell if you have this one
Check for the product name 'Smith & Nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT' and reference number 71421164. This implant was sold with a batch number of 23LM03388.
- 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
US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0277-2025 | smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER; UDI/DI 03596010543820, Batch Number 23LM00479 | 3 units |
| Z-0278-2025 | smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER; UDI/DI 03596010543837, Batch Number 23LM03388 | 2 units |
What to do — step by step
Check Your Implant Details
Verify the implant's size and reference number against the product description provided in the recall notice.
Where it went and when
Where it was distributed
Distributed in Texas, and outside the U.S.
FDA distribution: “US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
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.
Questions people ask
Is this implant dangerous if used correctly?
The recall is due to the wrong size being shipped, not the implant itself being dangerous when used correctly.
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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-0278-2025 (October 2, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0278-2025 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.