Recall Z-1170-2025 ยท KNW Instrument, Biopsy
Hologic, Inc
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
| Date | Feb 13, 2025 (initiated Jan 15, 2025) |
| Status | Open, Classified |
| Reason | Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. |
| Root cause | Process control |
| Action | On January 15, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Our goal is to create as little disruption to your practice as possible. Below outlines the next steps for customers with affected product(s): " Please quarantine any product(s) from the impacted lots you currently have in your inventory. Impacted lots can be returned through IQVIA as part of the voluntary recall. Please note that you will be issued a credit on your account for the affected product(s). " Refer to the Customer Response Form Instructions to identify your product inventory that is subject to this ac |
| Quantity | 55,335 units |
| Distribution | Domestic: Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150169 | Sertera Biopsy Device Hologic, Inc., Aug 14, 2015 |