Device is used for treatment, not diagnosis.This report is for one radial head, 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 june, 2017.A device history review was conducted.The report indicates (b)(4) manufactured the 22mm cocr radial head 2mm extension, part #09.402.222 and lot #6892425 for (b)(4) parts delivered on june 11, 2012 and processed on work order #2926610.Initially, the part conformed to the supplier¿s certificate of conformance, dated june 6, 2012, and was inspected and conformed to the synthes final inspection sheet ns051180, revision ¿a¿.The parts were labeled, packaged, sterilized (po # 1402563) at (b)(4) and released to the warehouse on july 17, 2012, with expiration date june 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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