Smith & Nephew recalls specific EVOS Condylar Medial Distal Femur Plates due to incorrect MRI scanning instructions in the product manual, which could lead to improper surgical planning.
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Smith & Nephew is recalling certain EVOS Condylar Medial Distal Femur Plates because MRI scanning instructions in the product manual contained errors. This could lead to improper surgical planning if the incorrect data is used during procedures.
The recall is due to MRI scanning conditions in the product manual being based on incorrect data from previous reports. This error could lead to improper surgical planning if the wrong information is followed during procedures.
Patients who received the specific plate model with batch numbers 20HM10258, 20HM10259, 20HM10261, or 20HM22791 are likely affected. Surgeons and medical staff using these plates for orthopedic procedures are at the highest risk.
Check for the model name 'EVOS Condylar Medial Distal Femur Plate, R, 5H, 115MM' and batch numbers 20HM10258, 20HM10259, 20HM10261, or 20HM22791 on the product label.
Look for the model name and batch numbers listed in the recall notice to confirm if your product is affected.
Smith & Nephew is recalling these plates because MRI scanning conditions in the product manual contained errors from previous reports, which could lead to improper surgical planning.
The recall notice does not specify a remedy or action for affected products. Check the product label for batch numbers to confirm if it is affected.
The recall is for potential errors in surgical planning, not a direct risk of injury. The hazard level is low risk as the issue is related to incorrect data in the manual.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0366-2022 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0366-2022 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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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.
