Smith & Nephew recalls specific EVOS femur plates due to incorrect MRI scanning instructions that could lead to improper surgical planning. Affected units have batch numbers 20HM10252-20HM22785.
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Smith & Nephew is recalling specific femur plates that contain outdated MRI scanning instructions. This could lead to surgical errors if the incorrect data is used during procedures.
The recall involves MRI scanning instructions that were previously reported as incorrect. This error could lead to improper surgical planning if the outdated data is followed during procedures.
Surgical teams using the recalled plates for orthopedic procedures. Patients undergoing hip or knee surgery with these specific plates are most at risk.
Check for batch numbers 20HM10252, 20HM10253, 20HM10254, or 20HM22785 on the plate. The product is a Smith & Nephew EVOS Condylar Medial Distal Femur Plate, L, 5H, 115MM, REF 72573102.
Verify the batch number on the plate to see if it matches 20HM10252, 20HM10253, 20HM10254, or 20HM22785.
Testing vendor found that previous MRI scanning conditions in the reports were incorrect, which were then included in the surgical instructions.
Check the batch number on the plate. If it matches the listed numbers, contact Smith & Nephew for further instructions.
The recall is for potential surgical errors due to incorrect MRI data, but the product itself is not hazardous in normal use.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0365-2022 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0365-2022 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.
