Device is used for treatment, not diagnosis.This report is for one radial stem, catalog and lot numbers unknown.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Expiration date reported as november, 2017.A device history review was conducted.The report indicates nemcomed (now known as avalign technologies-nemcomed) manufactured the 8mm ti curved radial stem, part #04.402.028 and lot #7012349 on po #1412882 for 37 parts delivered on november 29, 2012 and processed on work order #3076417.Initially, the part conformed to the supplier¿s certificate of conformance, dated november 27, 2012 and was inspected and conformed to synthes final inspection sheet ns050780, revision ¿b¿.The parts were labeled, packaged, sterilized (po #1484566) at sterigenics (corona) and released to the warehouse on january 4, 2013, with expiration date november 2017.Device was used for treatment, not diagnosis.T was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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