Recall Z-2167-2024— Integra LifeSciences Corp.
Class II · Ongoing
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-05-29. It names one FDA 510(k) clearance: K141674. Product: 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. Reason: Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment.
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-29
- Firm location
- Princeton, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Reason for recall
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
Data sourced from openFDA. This site is unofficial and independent of the FDA.