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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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  Class 2 Device Recall Integra see related information
Date Initiated by Firm October 14, 2011
Date Posted March 15, 2012
Recall Status1 Terminated 3 on October 19, 2012
Recall Number Z-1215-2012
Recall Event ID 61093
510(K)Number K981262  
Product Classification Instrument, ultrasonic surgical - Product Code LFL
Product Integra CUSA EXcel Sterile Tips Rx Only
Single Use Only

Product Usage: For usage in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.
Code Information 510K #: K981262 Device Listing #: D001100 Item Number C4601S Lot #: 1112631 Lot #: 1112632 Lot #: 1112633 Lot #: 1112634 Lot #: 1112635 Lot #1113361
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact David Gronostajski
609-936-6822
Manufacturer 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
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action 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.
Quantity in Commerce 24
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LFL and Original Applicant = VALLEYLAB, INC.
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