Data Foundry

Medical device recalls 2021

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE — Class II medical device recall Z-0366-2022

Terminated recall by Smith & Nephew, Inc., reported 2021-12-22, distributed nationwide. Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports we

Recall numberZ-0366-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSmith & Nephew, Inc., Memphis, TN, United States
Recall initiated2021-11-01
Classified2021-12-10
Reported by FDA2021-12-22
Terminated2026-06-15
DistributedNationwide (US)
Quantity41 units
Lot numbers20HM10258, 20HM10259, 20HM10261, 20HM22791
Model numbers72573202

Product

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0366-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.