Smith & Nephew, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0366-2022)

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 CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202

Product Classification:

Class II

Date Initiated: November 1, 2021

Date Posted: December 22, 2021

Recall Number: Z-0366-2022

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: 41 units

Code Information:

Batch Number: 20HM10258, 20HM10259, 20HM10261, 20HM22791, 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.

Voluntary or Mandated:

Voluntary: Firm initiated