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Recall Observatory FDA recall evidence

Device product

smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201

Z-0364-2022

November 01, 2021

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 89031
Status
Terminated
Classification
Class II
Quantity
35 units
Official record key
device-enforcement:Z-0364-2022

Official wording

Reason: 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.

Code information: Batch Number: 20HM10255, 20HM10256, 20HM10257, UDI

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.