Smith & Nephew, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0363-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 1, 2021

Date Posted: December 22, 2021

Recall Number: Z-0363-2022

Event ID: 89031

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.

Status: Ongoing

Product Quantity: 38 units

Code Information:

Batch Number: 20HM10249, 20HM10250, 20HM10251, 20HM22783, UDI (01) 00885556752999 (17) 310630 (10) 12345678 (11) 2210630 (21) 87654321

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.

Voluntary or Mandated:

Voluntary: Firm initiated