Smith & Nephew EVOS femur plates recalled for erroneous MRI instructions
Smith & Nephew is recalling 38 EVOS femur plates because the product instructions contain erroneous MRI scanning conditions. The affected units were distributed nationwide across 14 states.
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: FDA Class II medical device recall involving erroneous safety information in product instructions. The source reports no illnesses or injuries, making this a theoretical risk-of-harm situation rather than documented harm, placing it at score 3 (High) per the severity rubric.
Plain-English summary
Smith & Nephew, Inc. is recalling the EVOS MEDIAL DISTAL FEMUR PLATE, a surgical implant used for fracture repair. A testing vendor identified that MRI scanning conditions provided in the product's Instructions For Use (IFU 81110294) were erroneous. This incorrect information could potentially affect the safe use of the device during MRI imaging procedures.
The recall affects 38 units distributed nationwide across 14 states: 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 20HM10249, 20HM10250, 20HM10251, and 20HM22783.
Patients and healthcare providers who have received or implanted this device should contact Smith & Nephew for updated, corrected instructions regarding MRI safety parameters. The device batch number should be verified to confirm whether the specific implant is part of this recall.
The recalled product
- Product
- smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- mri-safety-hazard
- instruction-error
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: 20HM10249
- 20HM10250
- 20HM10251
- 20HM22783
- UDI (01) 00885556752999 (17) 310630 (10) 12345678 (11) 2210630 (21) 87654321
Distribution
Distributed nationwide across the United States.
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