Integra LifeSciences Corp.: Device Recall

Recall Details

Recall Number

Z-2167-2024

Classification

Class II

Product Type

Device

Recalling Firm

Integra LifeSciences Corp.

Status

Ongoing

Date Initiated

05/29/2024

Location

Princeton, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2, 652 units

Reason for Recall

Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment

Product Description

CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see C2600P or C2600SRL on labeling. This notice is applicable for those SKUs as well

Distribution Pattern

Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia (Plurinational State of) Brazil Canada Chile China Costa Rica Dominican Republic (the) El Salvador Hong Kong India Indonesia Japan Korea (the Republic of) Malaysia Mexico Mongolia Myanmar Nepal New Zealand Pakistan Panama Peru Philippines (the) Puerto Rico Singapore Sri Lanka Taiwan (Province of China) Thailand Viet Nam

Other Recalls by Integra LifeSciences Corp.

• Class II: Risk 02/06/2025
  Possibility for the obturator to break (separate).
• Class II: Risk 01/10/2025
  Potential that the induction seal is not completely sealed to the device tube packaging.
• Class II: Risk 12/16/2024
  Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
• Class II: Risk 12/16/2024
  Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
• Class II: Risk 12/16/2024
  Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

View all recalls by Integra LifeSciences Corp. →