EVOS Medial Distal Femur Plate IFU contains erroneous MRI scanning conditions
Smith & Nephew recalled EVOS Medial Distal Femur Plates because the Instructions for Use contain erroneous MRI scanning data that was incorrectly incorporated from a vendor report.
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 recall involving incorrect MRI scanning instructions in medical device documentation. The erroneous data presents a potential risk of harm to patients, though no illnesses or injuries have been reported in the recall notice.
Plain-English summary
Smith & Nephew, Inc. is recalling the EVOS Medial Distal Femur Plate (Reference 72573201) due to erroneous data in the Instructions for Use (IFU 81110294) for the EVOS Large Fragment Plating System.
A testing vendor notified Smith & Nephew that MRI scanning conditions previously provided in vendor reports were erroneous. This erroneous data was incorporated into the medical device instructions that are distributed to healthcare facilities.
Thirty-five units of the recalled device were distributed nationwide to medical facilities in Colorado, Florida, Georgia, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Washington. The affected batch numbers are 20HM10255, 20HM10256, and 20HM10257.
Healthcare providers and patients with these implants should contact Smith & Nephew for corrected guidance on MRI scanning conditions for this device.
The recalled product
- Product
- smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
- 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 (4)
- Batch Number: 20HM10255
- 20HM10256
- 20HM10257
- UDI
Distribution
Distributed nationwide across the United States.
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