FDAAugust 2, 2016device
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Tip Breakage at the glue joint between the obturator body and tip
What to do
FDA enforcement status: Terminated
Brands named
hologic
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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