Smith & Nephew Knee Implants Recalled for Mismatched Components

Agency Publication Date: October 31, 2024

Summary

Smith & Nephew Inc. has recalled 13 units of knee replacement implants because they may contain the wrong component inside the package. Specifically, a package labeled as a GENESIS II left-side knee component may actually contain a LEGION OXINIUM right-side component. While no injuries have been reported, one complaint was received regarding this packaging error which occurred at the manufacturing facility.

Risk

If a surgical team relies on the external package label, they may open a package that contains an implant with the incorrect size or orientation (right vs. left) for the patient's surgery. This mismatch can lead to unexpected surgical delays while a correct component is sourced or the potential for an improper fit if not identified.

What You Should Do

This recall involves Smith & Nephew knee replacement implants, specifically the GENESIS II Nonporous Posterior Stabilized Femoral Component (Size 5 Left) and the LEGION OXINIUM Posterior Stabilized Nonporous Femoral Component (Size 5N, Right, Narrow).
Check your inventory for product REF 71421015 (Batch 23LM02331) or product REF 71421275 (Batch 23LM02905).
Stop using the recalled device and quarantine any affected units immediately to ensure they are not used in surgical procedures.
Contact Smith & Nephew or your medical distributor to arrange for the return, replacement, or correction of the affected units.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT

Variants: Size 5 Left, Uncoated knee femur prosthesis, Metallic

Model / REF:

71421015

Lot Numbers:

23LM02331

UDI:

03596010469212

Recall #: Z-0281-2025; Quantity: 5 units

Product: smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT

Variants: Size 5N, Right, Narrow, Uncoated knee femur prosthesis, Metallic

Model / REF:

71421275

Lot Numbers:

23LM02905

UDI:

00885556234204

Recall #: Z-0282-2025; Quantity: 8 units

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95494

Status: Active

Manufacturer: Smith & Nephew Inc

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 2 products (5 units; 8 units)

Distributed To: Mississippi, Tennessee, North Carolina, California, Georgia, Delaware, Alabama

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.

Summary

Risk

What You Should Do

This recall involves Smith & Nephew knee replacement implants, specifically the GENESIS II Nonporous Posterior Stabilized Femoral Component (Size 5 Left) and the LEGION OXINIUM Posterior Stabilized Nonporous Femoral Component (Size 5N, Right, Narrow).

Check your inventory for product REF 71421015 (Batch 23LM02331) or product REF 71421275 (Batch 23LM02905).

Stop using the recalled device and quarantine any affected units immediately to ensure they are not used in surgical procedures.

Contact Smith & Nephew or your medical distributor to arrange for the return, replacement, or correction of the affected units.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Affected Products

Product: smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT

Variants: Size 5 Left, Uncoated knee femur prosthesis, Metallic

Model / REF:

71421015

Lot Numbers:

23LM02331

UDI:

03596010469212

Recall #: Z-0281-2025; Quantity: 5 units

Product: smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT

Variants: Size 5N, Right, Narrow, Uncoated knee femur prosthesis, Metallic

Model / REF:

71421275

Lot Numbers:

23LM02905

UDI:

00885556234204

Recall #: Z-0282-2025; Quantity: 8 units

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95494

Status: Active

Manufacturer: Smith & Nephew Inc

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 2 products (5 units; 8 units)

Distributed To: Mississippi, Tennessee, North Carolina, California, Georgia, Delaware, Alabama