Z-0363-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 22, 2021
- Initiation Date
- November 1, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 units
Product Description
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
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 Pattern
US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.
Code Information
Batch Number: 20HM10249, 20HM10250, 20HM10251, 20HM22783, UDI (01) 00885556752999 (17) 310630 (10) 12345678 (11) 2210630 (21) 87654321