Smith & Nephew recalls specific femur plates due to incorrect MRI scanning instructions in the product manual that could lead to improper use. Affected models include REF 72573201 with batch numbers 20HM10255-20HM10257.
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 because MRI scanning instructions in the product manual were incorrect. This could lead to improper surgical procedures if the device is used without the updated instructions.
The recall is triggered by erroneous MRI scanning data that was included in the product manual. This incorrect information could lead to improper surgical procedures if the device is used without the updated instructions.
Orthopedic surgeons and medical professionals who use the Smith & Nephew EVOS Medial Distal Femur Plate with batch numbers 20HM10255-20HM10257 are affected. Patients receiving this specific surgical implant may also be impacted.
Check for the product name 'EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM' with reference number 72573201 and batch numbers 20HM10255, 20HM10256, or 20HM10257.
Check if your device's manual includes the incorrect MRI scanning instructions from the released IFU 81110294 EVOS Large Fragment Plating System.
Smith & Nephew received notification from a testing vendor that previous MRI scanning conditions in their reports were erroneous and were incorporated into the product manual.
The affected models are Smith & Nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM with reference number 72573201 and batch numbers 20HM10255, 20HM10256, and 20HM10257.
No, the recall does not require immediate discontinuation. However, you should review the product manual for updated MRI scanning instructions.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0364-2022 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0364-2022 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.
