The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history review was conducted.The report indicates (b)(6) technologies-(b)(6) manufactured the 7mm ti straight radial stem, part #04.402.007 and lot #7133464 on po #(b)(4) dated (b)(6) 2013 for (b)(4) parts processed on work order #(b)(4).Initially, the part conformed to the supplier¿s certificate of conformance, dated (b)(6) 2013 and was inspected and conformed to synthes final inspection sheet (b)(6).The parts were labeled, packaged, sterilized (po #(b)(4)) at sterigenics (corona) and released to the warehouse on (b)(6) 2013, with expiration date (b)(6) 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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