Z-2035-2023 Class II Ongoing
FDA device recall Z-2035-2023 was initiated by Hologic, Inc on May 2, 2023 and is designated Class II. Reason for recall: The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery The recall status is ongoing. Affected quantity: 756 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- May 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 756 units
Product Description
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Reason for Recall
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 15420045504066 Lot Number: E22H19RM