Smith & Neph: Recalled knee implant due to wrong model in package
Smith & Nephew recalls a specific knee implant model that was shipped with the wrong component. This could lead to improper fitting and potential complications during surgery.
Lower-risk recall
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Contact the company
What happened, in plain English
Smith & Nephew is recalling a specific knee implant model because it was shipped with the wrong component in some packages. Using this incorrect implant could lead to improper fitting and potential complications during surgery. Read more at govinfonow.com/recall/53836-smith-neph-recalled-knee-implant-due-to-wrong-model-in.
Source Summary by GovInfoNow · govinfonow.com/recall/53836-smith-neph-recalled-knee-implant-due-to-wrong-model-in · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0282-2025
Cite this page
“Smith & Neph: Recalled knee implant due to wrong model in package.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/53836-smith-neph-recalled-knee-implant-due-to-wrong-model-in. Based on FDA recall #Z-0282-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0282-2025%22&limit=1).
Why it’s dangerous
The recalled implant was shipped with the wrong model (LEGION NARROW PS OXIN SZ 5N RIGHT) instead of the intended model (GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT). This mismatch could cause improper fitting during surgery, potentially leading to complications.
Who’s affected
Patients who received this specific knee implant model during surgery are likely affected. Surgeons and medical staff who handled the recalled implant are at higher risk.
How to tell if you have this one
Check for the model number 'LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW' on the implant package. The product has a unique identifier (UDI/DI) of 00885556234204 and batch number 23LM02905.
- 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 states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0281-2025 | smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic; UDI/DI 03596010469212, Batch number 23LM02331 | 5 units |
| Z-0282-2025 | smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic; UDI/DI 00885556234204, Batch number 23LM02905 | 8 units |
What to do — step by step
Check Implant Model
Verify the model number on the implant package to confirm if it matches the recalled model.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
FDA distribution: “US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Delaware, Georgia, Mississippi, North Carolina, Tennessee.
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 model 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-0282-2025 (October 2, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0282-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.