Device is used for treatment, not diagnosis.Event date: unknown.This report is for a 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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Additional narrative: a review of the device history records was completed: nemcomed (now known as avalign technologies-nemcomed) manufactured the 24mm cocr radial head std ht/13mm, part 09.402.024 and lot 6892440.Initially, the part conformed to the supplier¿s certificate of conformance and was inspected and conformed to the synthes final inspection sheet.The parts were labeled, packaged, sterilized at (b)(4) and released to the warehouse on july 13, 2012, with expiration date june 30, 2017.There were no material review reports, non-conformance reports, 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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