Class 2 Device Recall Sertera Biopsy Device

• Date Initiated by Firm: January 15, 2025
• Date Posted: February 13, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1170-2025
• Recall Event ID: 96075
• 510(K)Number: K150169
• Product Classification: Instrument, biopsy - Product Code KNW
• Product: 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
• Code Information: Model No- Sertera-14; UDI- 15420045504066; Lot Numbers: E23B23RL, E23B23RM, E23C07RD, E23C07RF, E23C31RC, E23D12RT, E23D12RU, E23D27RW, E23E03RJ, E23E12RT, E23E12RU, E23E29RL, E23E30RM, E23F02RG, E23F07RL, E23F07RM, E23F27R, E23F29RL, E23F29RM, E23F29RN, E23G12RK, E23G25R, E23G31RL, E23H02R, E23H02RA, E23H02RB, E23H28RA, E23H31RF, E23H31RG, E23K02RL, E23K10R, E23K10RA, E23K10RB, E23K31RU, E23L06RK, E23L10RB, E23L22RV, E23L28RB, E23L28RD, E23M21RV, E24A08RL, E24A08RM, E24A26RD, E24B01RF, E24B07RK, E24B22RC, E24B28R, E24B28RA, E24C07RA, E24C21R, E24D26RF, E24E02RD, E24E15RA, E24E22R, E24E22RA, E24E24RB.
• FEI Number: 1000120743
• Recalling Firm/ Manufacturer: Hologic, Inc; 250 Campus Dr; Marlborough MA 01752-3020
• For Additional Information Contact: Breast Health Customer Support; +1-877-3714372
• Manufacturer Reason for Recall: Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
• FDA Determined 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 action. " Confirm receipt of this communication by completing the online Customer Response Form. Please complete and submit the online Customer Response Form even if you no longer have the affected product in inventory. Hologic has partnered with IQVIA to conduct follow up communications should no response be received to this letter. " Hologic will issue a Return Goods Authorization upon receipt of the Customer Response Form and the return of all affected products to Hologic. " If you wish to reorder product, please place a new order via your preferred procurement method. We value your business and thank you for your cooperation. If you have any questions about this communication, please contact BreastHealth.Support@hologic.com or 1-877-371-4372.
• Quantity in Commerce: 55,335 units
• Distribution: Domestic: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KNW