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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Additional narrative: additional patient identifier: (b)(6).Expiration date reported as january 2018.A device history review was conducted.The report indicates nemcomed (now known as avalign technologies-nemcomed) manufactured the 10mm ti straight radial stem, part #04.402.010 and lot #7012270 on po #(b)(4) for (b)(4) parts delivered on january 2, 2013 and processed on work order #(b)(4).Initially, the part conformed to the supplier¿s certificate of conformance, dated december 28, 2012 and was inspected and conformed to synthes final inspection sheet (b)(4), revision ¿b.¿ the parts were labeled, packaged, sterilized (po #(b)(4)) at (b)(4) and released to the warehouse on march 8, 2013 with expiration date january 2018.There were no mrr¿s, ncr¿s, or complaint related issues with this lot.Device was used for treatment, not diagnosis.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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