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Smith & Nephew, Inc. Recall 89031

Description: smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

Smith & Nephew, Inc. Recall 89031 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0363-2022
Event ID89031
Event Descriptionsmith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Product TypeDevices
DistributionUS Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.
Quantity38 units
Recall ReasonTesting vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent s reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Device Classification20211222
Device Code InfoBatch Number: 20HM10249, 20HM10250, 20HM10251, 20HM22783, UDI (01) 00885556752999 (17) 310630 (10) 12345678 (11) 2210630 (21) 87654321
Center Classification Date20211210
Recall Initiation Date20211101
Recalling FirmSmith & Nephew, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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