Smith & Nephew, Inc.: K-Wires Recalled Due to Packaging Error and Incorrect Sizing

Agency Publication Date: September 19, 2024

Summary

Smith & Nephew, Inc. has recalled approximately 97 units of its K-Wires, which are metallic fasteners used for bone fixation. The recall was initiated after a report revealed that some packages labeled as .045-inch diameter wires actually contained larger .062-inch diameter wires. Consumers and healthcare providers should contact the manufacturer to address any affected products identified in their inventory.

Risk

The use of an incorrectly sized K-Wire during a surgical procedure could lead to improper bone fixation, potential bone damage from using a larger wire than intended, or surgical delays while seeking a correct replacement.

What You Should Do

Identify if you have the affected products by checking for 'DIAMOND POINT, BOTH ENDS K-WIRE' with Reference Number 128042 and Batch/Lot 23GNX0077.
Check your inventory for 'DIAMOND POINT, BOTH ENDS K-WIRE' with Reference Number 128062 and Batch/Lot 21KNX0074.
Immediately stop using any K-Wires that match the affected reference and batch numbers mentioned above.
Contact Smith & Nephew, Inc. at their Memphis, Tennessee headquarters or through your authorized representative to arrange for the return or replacement of the mislabeled units.
Contact your healthcare provider if you have concerns about a procedure where these devices may have been used.
For further questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Field action to voluntarily remove batches

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener

Model / REF:

128042

Lot Numbers:

23GNX0077

Product: DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

Model / REF:

128062

Lot Numbers:

21KNX0074

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95154

Status: Active

Manufacturer: Smith & Nephew, Inc.

Sold By: Hospital and surgical supply channels

Manufactured In: United States

Units Affected: 2 products (24 units; 73 units)

Distributed To: Nationwide

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

What You Should Do

Identify if you have the affected products by checking for 'DIAMOND POINT, BOTH ENDS K-WIRE' with Reference Number 128042 and Batch/Lot 23GNX0077.

Check your inventory for 'DIAMOND POINT, BOTH ENDS K-WIRE' with Reference Number 128062 and Batch/Lot 21KNX0074.

Immediately stop using any K-Wires that match the affected reference and batch numbers mentioned above.

Contact Smith & Nephew, Inc. at their Memphis, Tennessee headquarters or through your authorized representative to arrange for the return or replacement of the mislabeled units.

Contact your healthcare provider if you have concerns about a procedure where these devices may have been used.

For further questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.