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 |
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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.
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510(K) Database | 510(K)s with Product Code = LFL
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