Smith & Nephew Legion Hemi Step Tibial Wedge Recall: Incorrect Screw Component

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Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Smith & Nephew is recalling certain constrained knee implants because they were packaged with the wrong screw component. This could lead to improper surgical fixation if used without correction.

Why it’s dangerous

The implants were packaged with an incorrect screw component, which could cause improper surgical fixation if used without correction. This might lead to complications during or after knee surgery.

Who’s affected

Patients who received the recalled constrained knee implants during surgery are affected. Surgeons and medical staff who used these implants are at higher risk.

How to tell if you have this one

Check for the product name 'LEGION HEMI STEP TIBIAL WEDGE RK/HK', size 3-4, and reference number 71423432. These implants are used in constrained knee surgeries.

Brand
Smith & Nephew
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to Smith & Nephew for guidance on the correct implant replacement.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The affected products were inadvertently packaged with an incorrect screw component.

What should I do if I have this product?

Contact Smith & Nephew for guidance on the correct implant replacement.

Is there a risk of serious injury?

The recall is due to packaging error, not a direct risk of injury. The hazard is low risk.

Take action

Contact Smith & Nephew

We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2538-2019 — Smith & Nephew Smith & Nephew

Hello,

I own a Smith & Nephew that is covered by recall Z-2538-2019 from Smith & Nephew.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-2538-2019 (January 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2538-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.

Smith & Nephew, Inc. recalls LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee

Lower-risk recall