Integra Cusa Excel Rx Only CEM" Nosecone for CUSA Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + U

FDA device recall Z-0994-2014 · posted 2014-02-20 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.

Action taken

Integra sent an Urgent: Medical Device Correction Letter/Acknowledgement Return Form dated December 5, 2013 via traceable courier to their customers. The notification: advises customers of the nature of the issue and how it could affect CEM Nosecone use, advises customers what to do if the issue occurs and requests customers complete and return the Acknowledgment Return Form. The form should be faxed to rc@integralife.com or 1-609-275-9445. Any questions can be directed to customer service at 855-532-1723.

Root cause

Material/Component Contamination

Status

Terminated

Quantity affected

17253 boxes

Distribution

Worldwide Distribution - USA Nationwide

Date initiated

2013-12-05

Date posted

2014-02-20

Date terminated

2017-01-26

Location

Plainsboro, NJ