Device 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)
Z-2765-2016
Product summary
- Firm
- Hologic, Inc
- Event
- Event 74839
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1440 units
- Official record key
device-enforcement:Z-2765-2016
Official wording
Reason: Tip Breakage at the glue joint between the obturator body and tip
Code information: Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Tip Breakage at the glue joint between the obturator body and tip