smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Check against the official notice below — it lists the full affected range.
Smith & Nephew is recalling the EVOS Medial Distal Femur Plate (model L, 5H, 90MM, reference 72573101) due to incorrect MRI safety information in the product's instructions for use. A testing vendor discovered that the MRI scanning conditions included in the accompanying documentation were erroneous, and this faulty data was incorporated into the released instructions. A total of 38 units across four batch numbers were distributed nationwide to medical facilities in 16 states: Colorado, Florida, Georgia, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Washington.
The recall record does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA. Quantity: 38 units Lot/code info: Batch Number: 20HM10249, 20HM10250, 20HM10251, 20HM22783, UDI (01) 00885556752999 (17) 310630 (10) 12345678 (11) 2210630 (21) 87654321
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.