Integra LifeSciences Corp.: CUSA Excel 23KHz Straight Handpiece Recalled for Potential Housing Cracks

Agency Publication Date: June 21, 2024

Summary

Integra LifeSciences is recalling approximately 2,652 CUSA Excel C2600 23KHz Straight Handpieces because the housing on the device can crack. This surgical tool is used to break up and remove tissue during operations; if the housing fails, it can lead to a delay in treatment while a replacement is found. This recall affects units manufactured before November 1, 2023, and distributed nationwide and internationally.

Risk

A cracked handpiece housing can cause the device to malfunction or fail during a surgical procedure. This necessitates stopping the surgery to replace the equipment, which poses a risk of harm to the patient due to prolonged anesthesia or a delay in the medical intervention.

What You Should Do

Identify if your surgical handpiece is affected by checking the model and serial number. The recall applies to CUSA Excel C2600 23KHz Straight Handpieces (which may also be labeled as C2600P or C2600SRL) with UDI-DI 10381780039419.
Verify the serial number on the device or its packaging. Affected units include all serial numbers distributed before December 14, 2023, and those with codes starting with 'HA' followed by a month letter (A through L) and the year '23'. Specifically, any serial number manufactured prior to HAL23XXXXXXIE is included.
Contact your healthcare facility's equipment manager or Integra LifeSciences Corp. directly at 1100 Campus Rd, Princeton, NJ to determine if your specific unit requires replacement or further inspection.
If a device is found to be cracked or part of the affected lot, follow the manufacturer's specific instructions for returning the unit or receiving a replacement.
Consult with your healthcare provider if you have concerns about a procedure where this device was used.
For additional questions or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and device management

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

Affected Products

Product: CUSA Excel C2600 23KHz Straight Handpiece

Model / REF:

C2600

C2600P

C2600SRL

UPC Codes:

10381780039419

Lot Numbers:

All serial numbers distributed before 12/14/2023

Serial numbers manufactured prior to HAL23XXXXXXIE

Date Ranges: Distributed before December 14, 2023, Manufactured before November 1, 2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94724

Status: Active

Manufacturer: Integra LifeSciences Corp.

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 2, 652 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 your surgical handpiece is affected by checking the model and serial number. The recall applies to CUSA Excel C2600 23KHz Straight Handpieces (which may also be labeled as C2600P or C2600SRL) with UDI-DI 10381780039419.

Verify the serial number on the device or its packaging. Affected units include all serial numbers distributed before December 14, 2023, and those with codes starting with 'HA' followed by a month letter (A through L) and the year '23'. Specifically, any serial number manufactured prior to HAL23XXXXXXIE is included.

Contact your healthcare facility's equipment manager or Integra LifeSciences Corp. directly at 1100 Campus Rd, Princeton, NJ to determine if your specific unit requires replacement or further inspection.

If a device is found to be cracked or part of the affected lot, follow the manufacturer's specific instructions for returning the unit or receiving a replacement.

Consult with your healthcare provider if you have concerns about a procedure where this device was used.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: CUSA Excel C2600 23KHz Straight Handpiece

Model / REF:

C2600

C2600P

C2600SRL

UPC Codes:

10381780039419

Lot Numbers:

All serial numbers distributed before 12/14/2023

Serial numbers manufactured prior to HAL23XXXXXXIE

Date Ranges: Distributed before December 14, 2023, Manufactured before November 1, 2023