No fault could be found with the returned reference sensor, rs2 s/n (b)(4).The rs passed all visual and functional tests.A review of the device history record (dhr) was conducted.There were no process deviations (pds) or nonconforming material reports (ncmrs) within the dhr.The device passed all manufacturing specifications prior to release.The root cause cannot be determined; no fault could be found with the returned part.Orthalign will continue to monitor this issue and take action if or when alert limits are exceeded.
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