Integra CUSA Excel CEM Nosecone Recalled for Sticking Button
Integra LifeSciences is recalling CUSA Excel CEM nosecones because the blue COAG button may stick in the activated position.
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Integra LifeSciences Corp. is recalling the CUSA Excel CEM Nosecone, a medical device used with the CUSA Excel Ultrasonic Surgical Aspiration System. The recall involves 17,253 boxes of the product, which were distributed worldwide and nationwide in the United States.
The recall was initiated because the blue COAG button on the nosecone could stick in the 'activated' position. This defect could potentially affect the device's intended function during surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired.
Healthcare facilities and users should stop using the affected CEM Nosecones and contact Integra LifeSciences for further instructions or replacement. The recall covers all unexpired lot numbers for Catalogue Nos. C6623 and C6636 manufactured from January 1, 2010, to the present.
The recalled product
- Product
- Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 17,253
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 (20)
- Catalogue No. C6623: 1083655
- 1084219
- 1084398
- 1084399
- 1084400
- 1084682
- 1084683
- 1090937
- 1091712
- 1091714
- 1091715
- 1093125
- 1093126
- 1093128
- 1093129
- 1093471
- 1093847
- 1094575
- 1094740
- 1095587
Distribution
Distributed nationwide across the United States.
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