FDA (Devices) recall action 74562
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Stryker Instruments is voluntarily recalling specific lots of 5.0mm Round Fluted Burs because tarnishing or corrosion may cause inflammation requiring surgery.
Stryker is voluntarily recalling specific lots of 6.0mm Round Fluted Burs due to potential tarnishing or corrosion that could cause inflammation requiring surgery.