Integra CUSA CEM Nosecone Recalled for Potential Tip Erosion
Integra LifeSciences is recalling CEM Nosecones for the CUSA EXcel system due to a potential for tip erosion and breakage. No patient injuries have been reported.
What this means for you
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 involves a medical device with a risk of harm (tip breakage) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Integra LifeSciences Corp. is recalling CEM Nosecones for the CUSA EXcel System. The recall involves specific lot numbers of Catalogue No. C6623 and C6636. The affected units were distributed worldwide, including in the United States, Europe, and other international markets.
The recall is issued because there is a potential for erosion of the CUSA EXcel tip when used with the Nosecone. This erosion can occur if the side of the tip, rather than the annulus, is in contact with tissue during use. The erosion can potentially lead to tip breakage.
There were no reports of patient injury associated with these complaints. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
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)
- CEM Nosecone Catalogue No. C6623 Lot numbers: 1092855
- 1093129
- 1100436
- 1100437
- 1101217
- 1101328
- 1103393
- 1104265
- 1105067
- 1110311
- 1110892
- 1112182
- 1112183
- 1114112
- 1114655
- 1115225
- 1115499
- 1115500
- 1120771
- 1121141
Distribution
Distribution scope not specified by the agency.
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