Device product
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Z-2035-2023
Product summary
- Firm
- Hologic, Inc
- Event
- Event 92357
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 756 units
- Official record key
device-enforcement:Z-2035-2023
Official wording
Reason: The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Code information: UDI-DI: 15420045504066 Lot Number: E22H19RM
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery