Device is used for treatment, not diagnosis.This report is for one unknown 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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(b)(6).Expiration date reported as may 2017.A device history review was conducted.The report indicates that (b)(4) manufactured the 7mm ti straight radial stem, part #04.402.007 and lot #7012150 on po #1412708 for (b)(4) parts delivered on november 15, 2012 and processed on work order #3076207.Initially, the part conformed to the supplier¿s certificate of conformance, dated november 12, 2012 and was inspected and conformed to synthes final inspection sheet ns050779, revision ¿b¿.The parts were labeled, packaged, sterilized (po #1484566) at (b)(4) and released to the warehouse on january 4, 2013, with expiration date october 2017.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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