Reported Jul 3, 2024 · Ongoing
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration
- of soft and hard tissue Catalog NumberC2600* *Note: you may see C2600P or C2600SRL on labeling. This notice is applicable for those SKUs as well
- Lot codes and dates
- UDI-DI10381780039419 All serial numbers distributed before 12/14/2023 Product manufactured before 11/01/2023
- SNHandpiece manufactured Prior to HAL23XXXXXXIE (represents a product
- that is manufactured in November 2023)HA indicating the product family Letter indicating the month of manufacture where A = January; B = February, L=November. Two digits e.g 23 indicating the year of manufacture with 23 representing 2023
- Amount recalled
- 2, 652 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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