Z-0365-2022Class II

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102

Name: Z-0365-2022 smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Creator: Smith & Nephew, Inc.
Published: 2021-11-01
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2021-11-01 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102 on 2021-11-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0365-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-01
Posted: 2021-12-10
Terminated: 2026-06-15
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm initiated the correction by email and letter on 1 NOV 2021. The notice explained the problem and requested that the consignees check their inventory and complete the Inventory Correction Certificate form. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out.
Quantity in commerce: 35 units
Distribution: US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.
Product codes and lots: Batch Number: 20HM10252, 20HM10253, 20HM10254, 20HM22785, UDI

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0365-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0363-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0364-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0365-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-10
Z-0366-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-10

Product code HRS

K201918Class IIEVOS Large Fragment Plating SystemSmith & Nephew, Inc. / cleared 2020-11-16

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)