Recall Z-2035-2023 ยท KNW Instrument, Biopsy
Hologic, Inc
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
| Date | Jun 29, 2023 (initiated May 2, 2023) |
| Status | Open, Classified |
| Reason | The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery |
| Root cause | Device Design |
| Action | Hologic issued Urgent Medical Device Correction letter on 5/2/23. Letter states reason for recall, health risk and action to take: " Please properly dispose of any product(s) from this lot you currently have in your inventory. You will be issued a credit on your account for the affected product(s). If you wish to reorder product, please place a new order via your preferred procurement method. " Complete the online Customer Confirmation Form using the link below within 3 business days of receiving this notice. Replying promptly will confirm your receipt of the notification and prevent you from |
| Quantity | 756 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150169 | Sertera Biopsy Device Hologic, Inc., Aug 14, 2015 |