CLASS II Device recall · Reported 22 Dec 2021 · FDA Enforcement Report

Evos Condylar Medial Distal Femur Plate, R, 5h recalled

Smith & Nephew is recalling Evos Condylar Medial Distal Femur Plate, R, 5h, distributed nationwide in the US. The recall was initiated on 1 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch Number: 20HM10258, 20HM10259, 20HM10261, 20HM22791, UDI

Quantity recalled41 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0366-2022
FDA event ID: 89031
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 1 Nov 2021
FDA classified: 10 Dec 2021
Reported: 22 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Nov 2021	Recall initiated by company
10 Dec 2021	Classified by FDA	+39 days
22 Dec 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.

Nationwide Colorado Florida Georgia Massachusetts Minnesota Missouri North Carolina New Jersey Nevada New York Ohio Oklahoma Pennsylvania Tennessee Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 89031

This product is part of a recall event; the main page for the event is Evos Medial Distal Femur Plate, L, 5h recalled by Smith & Nephew.

Reported	Class	Recall	Company	Reason	Where
22 Dec 2021	CLASS II	Evos Medial Distal Femur Plate, L, 5h recalled by Smith & Nephew	Smith & Nephew	Other	Nationwide
22 Dec 2021	CLASS II	Evos Condylar Medial Distal Femur Plate, L, 5h recalled	Smith & Nephew	Other	Nationwide
22 Dec 2021	CLASS II	Evos Medial Distal Femur Plate, R, 5h recalled by Smith & Nephew	Smith & Nephew	Other	Nationwide

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