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There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the specified range.
Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly.
Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.