—#107298

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.

FDA product code: LFL — Instrument, Ultrasonic Surgical
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K981262
Affected lot / code info: 510K #: K981262 Device Listing #: D001100 Item Number C4601S Lot #: 1112631 Lot #: 1112632 Lot #: 1112633 Lot #: 1112634 Lot #: 1112635 Lot #1113361

Why it was recalled

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

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp
Address: 105 Morgan Ln, Plainsboro, New Jersey 08536-3339

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2011-10-14
Posted by FDA: 2012-03-15
Terminated: 2012-10-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107298. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.