FDA Recalls CUSA Excel Surgical Handpiece for Housing Cracks
Integra LifeSciences is recalling CUSA Excel C2600 surgical handpieces due to potential housing cracks that may delay treatment. The recall affects 2,652 units distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with a potential structural defect that could affect surgical function but without reported injuries or illnesses. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High.
Plain-English summary
The CUSA Excel C2600 23KHz Straight Handpiece, a surgical device used for fragmenting, emulsifying, and aspirating soft and hard tissue, is being recalled by Integra LifeSciences Corp. The recall involves 2,652 units with specific serial number ranges.
The handpiece housing may crack, which could potentially delay surgical treatment. This is a Class II recall from the FDA.
The affected devices were manufactured before November 1, 2023, and distributed nationwide as well as to multiple international locations including Canada, Mexico, Australia, Japan, and others. Healthcare facilities and surgical centers that possess affected units should review their inventory using the provided serial number information and contact Integra LifeSciences for guidance on replacement or remedy.
The recalled product
- 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…
- Manufacturer
- Integra LifeSciences Corp.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- B = February
Distribution
Distributed nationwide across the United States.
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