Smith & Nephew Genesis II Knee Bushing Recall: Laser Marking Error

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Smith & Nephew is recalling a specific lot of Genesis II knee bushings due to a laser marking error that could lead to incorrect implant placement. This affects patients who received the recalled lot number 16MM00441.

Why it’s dangerous

The left valgus bushing was incorrectly labeled as right and vice versa due to a laser marking error. This could lead to improper knee alignment during surgery, potentially causing incorrect implant placement.

Who’s affected

Patients who received the Genesis II knee system with lot number 16MM00441 are affected. Those with the specific laser marking error are at risk of incorrect implant placement.

How to tell if you have this one

Check for the lot number 16MM00441 on the Genesis II knee bushing. The product is part of the Smith & Nephew Genesis II Knee System with catalog number 71440014.

Brand
Smith & Nephew
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Verify Lot Number
Check the lot number on the bushing; affected units have lot number 16MM00441.

✎ GovInfoNow

Questions people ask

What is the specific lot number for the recalled bushing?

The recalled lot number is 16MM00441.

Why was this bushing recalled?

The bushing had a laser marking error that could cause incorrect implant placement.

How can I check if my bushing is affected?

Check the lot number on the bushing; affected units have lot number 16MM00441.

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-1902-2018 — Smith & Nephew Smith & Nephew

Hello,

I own a Smith & Nephew that is covered by recall Z-1902-2018 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-1902-2018 (April 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1902-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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 smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System

Lower-risk recall