Recall Z-2765-2016— Hologic, Inc
Class II · Terminated
Class II FDA medical device recall by Hologic, Inc, initiated 2016-08-02, terminated 2017-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece). Reason: Tip Breakage at the glue joint between the obturator body and tip.
- Recalling firm
- Hologic, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-02
- Terminated
- 2017-03-30
- Firm location
- Marlborough, MA, United States
Product description
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Reason for recall
Tip Breakage at the glue joint between the obturator body and tip
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