Smith & Nephew recalls specific femur plates due to erroneous MRI scanning data in instructions, potentially affecting surgical safety. Affected models include REF 72573101 with batch numbers 20HM10249-20HM10251 and 20HM22783.
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 medial distal femur plates that had incorrect MRI scanning data included in their instructions. This error could lead to improper surgical planning if the data is used without correction.
The recall involves MRI scanning data that was incorrectly reported in the product's instructions. This error could cause surgical planning issues if the data is used without correction, but it does not pose an immediate risk to patients during normal use.
Orthopedic surgeons and medical professionals using the recalled plates for femur repairs. Those with the specific model and batch numbers are most at risk.
Check for the model 'EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM' with batch numbers 20HM10249, 20HM10250, 20HM10251, or 20HM22783. The unique identifier (UDI) starts with 00885556752999.
Verify the batch number and unique identifier (UDI) on the product to confirm if it matches the recalled items.
The recall is due to erroneous MRI scanning data that was included in the product's instructions, which could affect surgical planning if not corrected.
The affected models are Smith & Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM with batch numbers 20HM10249, 20HM10250, 20HM10251, and 20HM22783.
No, the recall does not require immediate discontinuation. However, you should check the product details to confirm if it is affected.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0363-2022 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0363-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
