Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ult
FDA device recall Z-0920-2013 · posted 2013-03-08 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. This erosion can potentially lead to tip breakage. There were no reports of a patient injury associated with these complaints.
- Action taken
- Integra sent a Urgent Medical Device Recall Field Safety Notices dated January 7, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed of the nature of the issue and how if affects CUSA top erosion/breakage; advises customers and provided a copy of the CEM Nosecone IFU additional Warning; and requess customers to complete and return the Acknowledgement Return Form. Please feel free to contact our service hotline at ( 888 ) 772-7378.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LBK
- Quantity affected
- USA 6,190, EU 22,972 and ROW 288 units
- Distribution
- Worldwide Distribution - USA and the countries of Austria, Australia, Bangladesh, Belgium, Bulgaria, Brazil, Switzerland, Canada, China, Costa Rica, Czech Republic, Germany, Dominican Republic, Egypt,
- Date initiated
- 2013-01-07
- Date posted
- 2013-03-08
- Date terminated
- 2013-08-06
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K981262) | Valleylab, Inc. | 1998-07-06 |