Smith & Nephew Genesis II Knee Prosthesis Recall: Wrong Component Mix-Up
Smith & Nephew recalls Genesis II Non-Porous Cruciate Retaining Femoral Components with incorrect size mix-up. Affected lots include 16CMB0061A and 16CMB0066A. Contact for replacement.
Lower-risk recall
Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
Contact the company
What happened, in plain English
Smith & Nephew is recalling specific knee prostheses where the right size 6 component was shipped with a left size 4 component. This mix-up could lead to improper fitting and potential complications after surgery. Read more at govinfonow.com/recall/73267-smith-nephew-genesis-ii-knee-prosthesis-recall-wrong-component-mix.
Source Summary by GovInfoNow · govinfonow.com/recall/73267-smith-nephew-genesis-ii-knee-prosthesis-recall-wrong-component-mix · Updated September 19, 2026 · FDA enforcement record: FDA #Z-2883-2018
Cite this page
“Smith & Nephew Genesis II Knee Prosthesis Recall: Wrong Component Mix-Up.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73267-smith-nephew-genesis-ii-knee-prosthesis-recall-wrong-component-mix. Based on FDA recall #Z-2883-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2883-2018%22&limit=1).
Why it’s dangerous
The recall involves a mix-up where the right-side size 6 femoral component was packaged with a left-side size 4 component. This mismatch could cause improper alignment during surgery, potentially leading to complications like instability or improper function of the knee joint.
Who’s affected
Patients who received the recalled knee prostheses with lot numbers 16CMB0061A or 16CMB0066A are affected. Surgeons and medical facilities that used these components during implantation are at higher risk.
How to tell if you have this one
Check the lot number on the packaging or component label. The affected lots are 16CMB0061A and 16CMB0066A. This is a specific knee prosthesis model with the part number REF 71420026.
- Brand
Smith & Nephew- Category
Medical device
What to do — step by step
Check Component Lot Number
Identify the lot number on the knee prosthesis component label to see if it matches 16CMB0061A or 16CMB0066A.
How this recall unfolded
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
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-2883-2018 (August 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2883-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 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.