FDA (Devices) recall action 67183
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
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.
Biomet 3i is recalling 541 Contra-Angle Torque Driver Kits because the trays failed to meet required sterility assurance levels during validation testing.
Biomet 3i is recalling 181 dental torque driver kits because they failed to meet required sterility assurance levels during validation testing.
Biomet 3i is recalling 170 Tapered Navigator Certain Surgical Kits because the trays failed to meet required sterility assurance levels during validation testing.
Biomet 3i is recalling 250 Contra-Angle Torque Driver Kits because the included surgical trays failed to meet required Sterility Assurance Levels during validation testing.
Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit because the trays failed to meet required sterility assurance levels during validation testing.