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).A device history review was conducted.The report indicates nemcomed (now known as avalign technologies-nemcomed) manufactured the 22mm cocr radial head 4mm extension, part #09.402.422 and lot #6799733 for (b)(6) parts delivered on (b)(6) 2012 and processed on work order #(b)(4) and lot #6873718 for (b)(6) parts delivered on (b)(6) 2012 and processed on work order #(b)(4).Initially, the part conformed to the supplier¿s certificate of conformance, dated (b)(6) 2012 (lot #6799733) and (b)(6) 2012 (lot #6873718) and was inspected and conformed to the synthes final inspection sheet (b)(4), revision ¿a¿.The parts were released to the warehouse on (b)(6) 2012 (lot #6799733) and on (b)(6) 2012 (lot #6873718).Lot #6957967 was created to combine these two lots on work order #(b)(4) started on (b)(6) 2012.The parts were labeled, packaged, sterilized (po # (b)(4)) at (b)(6) ((b)(6)) and released to the warehouse on (b)(6) 2012, with expiration date may 31, 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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