FDA recall Z-2035-2023

Hologic, Inc · Class II · 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

Reason for recall

The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-05-02
Report date
2023-07-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2035-2023