Lower riskMedical device recall · FDA · Published November 1, 2021
Smith & Nephew EVOS Medial Distal Femur Plate Recall: MRI Scanning Data Error
Smith & Nephew recalls specific femur plates due to erroneous MRI scanning data in instructions, potentially affecting surgical safety. Affected models include REF 72573101 with batch numbers 20HM10249-20HM10251 and 20HM22783.
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent s reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
“Smith & Nephew EVOS Medial Distal Femur Plate Recall: MRI Scanning Data Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61612-smith-nephew-evos-medial-distal-femur-plate-recall-mri-scanning. Based on FDA recall #Z-0363-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0363-2022%22&limit=1).
The FDA announced on 2021-11-01 that Smith & Nephew, Inc. is recalling the smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE due to erroneous MRI scanning data in its instructions for use. The recall affects 38 units distributed nationwide.
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent’s reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Context
GovInfoNow's records show Smith & Nephew, Inc. has 66 other recalls on record since 2017-07-24. Other recent recalls of similar products include Smith & Nephew TRIGEN Humeral Nail Recall (2026-03-16), Smith & Nephew BIOSURE HA Screw Recall (2025-11-24), and Smith & Nephew META-TAN Screw Kit Recall (2025-03-18).
How to tell if you have this one
Check for the model 'EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM' with batch numbers 20HM10249, 20HM10250, 20HM10251, or 20HM22783. The unique identifier (UDI) starts with 00885556752999.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.
Verify the batch number and unique identifier (UDI) on the product to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Florida, Georgia, Massachusetts, Minnesota, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Washington.
Recall timeline
FDA terminated this recall 4.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0363-2022 (November 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0363-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.