Smith & Nephew, Inc.: 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.

Agency Publication Date: December 10, 2021

Affected Products

Product: smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

Batch Number: 20HM10249, 20HM10250, 20HM10251, 20HM22783, UDI (01) 00885556752999 (17) 310630 (10) 12345678 (11) 2210630 (21) 87654321

Lot Numbers:

Number

Product: smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201

Batch Number: 20HM10255, 20HM10256, 20HM10257, UDI

Lot Numbers:

Number

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

Batch Number: 20HM10252, 20HM10253, 20HM10254, 20HM22785, UDI

Lot Numbers:

Number

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

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

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89031

Status: Active

Manufacturer: Smith & Nephew, Inc.

Manufactured In: United States

Units Affected: 4 products (38 units; 35 units; 35 units; 41 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

Batch Number: 20HM10249, 20HM10250, 20HM10251, 20HM22783, UDI (01) 00885556752999 (17) 310630 (10) 12345678 (11) 2210630 (21) 87654321

Lot Numbers:

Number

Product: smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201

Batch Number: 20HM10255, 20HM10256, 20HM10257, UDI

Lot Numbers:

Number

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

Batch Number: 20HM10252, 20HM10253, 20HM10254, 20HM22785, UDI

Lot Numbers:

Number

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

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

Lot Numbers:

Number

Smith & Nephew, Inc.: 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.

Affected Products

Additional Information

Were You Affected by This Recall?

Smith & Nephew, Inc.: 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.

Affected Products

Additional Information

Were You Affected by This Recall?

Smith & Nephew, Inc.: 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.

Smith & Nephew, Inc.: 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.