Medtronic Sofamor Danek Usa, Inc - Dallas Saw Sagittal recall — FDA Z-2085-2016
Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
Overview of recall records associated with Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, including dates, categories and classifications where available.
Classification mix: Class II: 3.
Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
The wire pass hole is not present on the tools.
This page summarizes recall records in which the official source identifies Medtronic Sofamor Danek Usa, Inc - Dallas Distribution as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.