Z-0364-2022 Class II Terminated
FDA device recall Z-0364-2022 was initiated by Smith & Nephew, Inc. on November 1, 2021 and is designated Class II. 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 811102… The recall status is terminated (terminated June 15, 2026). Affected quantity: 35 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 22, 2021
- Initiation Date
- November 1, 2021
- Termination Date
- June 15, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
Product Description
smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
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: 20HM10255, 20HM10256, 20HM10257, UDI