Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the br
FDA device recall Z-2035-2023 · posted 2023-06-29 · Open, Classified
Recall details
- Recalling firm
- Hologic, Inc
- Reason for recall
- The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
- Action taken
- 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 receiving repeat notices. o www.novasyte.com/hologic/sertera-2023 " Hologic has partnered with IQVIA to conduct follow-up communications should no response be received to this letter. . If you have any questions, please do not hesitate to reach out to Technical Support at BreastHealth.Support@hologic.com
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KNW
- Quantity affected
- 756 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-05-02
- Date posted
- 2023-06-29
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sertera Biopsy Device (K150169) | Hologic, Inc. | 2015-08-14 |