Integra CUSA EXcel Sterile Tips Rx Only Single Use Only Product Usage: For usage in surgical procedures where fragmentat

FDA device recall Z-1215-2012 · posted 2012-03-15 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp

Reason for recall

A small number of non-conforming CUSA Excel 23 KHz Standard Tip and flue (item Number C4601S) were released for distribution that did not meet Integra's in-process requirements for release. It was discovered during in-process inspection that the max power reading exceeded the specification of 80 watts, causing the stroke range of the tip to exceed it required range by up a value up to 0.002 inches

Action taken

Integra sent an Urgent Product Recall Notification letter dated October 14, 2011 to all affected customers via US Mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory, discontinue use, quarantine and return any available affected lot numbers. Customers were instructed to distribute this communication to any customers to whom they have shipped the affected product. Customers were advise to complete the enclosed Recall Acknowledgement and Return Form and return it as soon as possible to Integra Customer Service. For questions contact Integra Customer Service at 609-936-2659.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

LFL

Quantity affected

24

Distribution

Worldwide Distribution

Date initiated

2011-10-14

Date posted

2012-03-15

Date terminated

2012-10-19

Location

Plainsboro, NJ

Related 510(k) clearances