Smith & Nephew EVOS Condylar Plate Recalled for Incorrect MRI Instructions
Smith & Nephew is recalling 41 units of the EVOS Condylar Medial Distal Femur Plate due to erroneous MRI scanning conditions in the instructions for use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall involving a risk-of-harm orthopedic implant with erroneous MRI safety instructions. Although no illnesses or injuries have been reported, the incorrect instructions pose a potential safety risk to patients with the implant who may undergo MRI scanning.
Plain-English summary
Smith & Nephew, Inc. is recalling the EVOS Condylar Medial Distal Femur Plate, Reference 72573202, used in orthopedic surgery. A total of 41 units were distributed nationwide to hospitals and healthcare facilities in Colorado, Florida, Georgia, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Washington.
The recall was initiated after a testing vendor notified Smith & Nephew that the instructions for use (IFU 81110294 for the EVOS Large Fragment Plating System) contain erroneous MRI scanning conditions. These incorrect conditions were derived from inaccurate data in prior Exponents reports and were inadvertently incorporated into the released instructions.
Patients who have received this implant and healthcare providers who may have used units from batch numbers 20HM10258, 20HM10259, 20HM10261, or 20HM22791 should contact Smith & Nephew for updated instructions and guidance. Affected facilities should verify they have the correct MRI scanning conditions before using remaining inventory.
The recalled product
- Product
- smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- incorrect-instructions
- mri-safety
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Batch Number: 20HM10258
- 20HM10259
- 20HM10261
- 20HM22791
- UDI
Distribution
Distributed nationwide across the United States.
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