FDA (Devices) recall action 86694
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.
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
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.
Coltene Whaledent Inc is recalling 556 packs of Alpen Clinic 100 Carbide Instruments because FG 557 burs were incorrectly packaged as FG 57 burs.
Coltene Whaledent is recalling 556 FG 57 dental burs that were incorrectly packaged as FG 557 burs, which remove more material.
Coltene Whaledent is recalling 556 CEI Cutting Edge Instruments (PTC-57C) because FG 557 burs were incorrectly packaged as FG 57 burs, which may remove more material.
Coltene Whaledent Inc is recalling Strauss 25 Carbide Dental Burs because they were incorrectly packaged as a different model, posing a risk of excessive material removal.
Coltene Whaledent is recalling FG 57 dental burs that were incorrectly packaged as FG 557 burs, which remove more material.