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U.S. Department of Health and Human Services

Class 2 Device Recall Sertera 14 Gauge Biopsy Device

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 Class 2 Device Recall Sertera 14 Gauge Biopsy Devicesee related information
Date Initiated by FirmMay 02, 2023
Date PostedJune 29, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2035-2023
Recall Event ID 92357
510(K)NumberK150169 
Product Classification Instrument, biopsy - Product Code KNW
ProductSertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Code Information UDI-DI: 15420045504066 Lot Number: E22H19RM
Recalling Firm/
Manufacturer		 Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
For Additional Information ContactBreast & Skeletal Health Customer Support
800-442-9892 Ext. 2
Manufacturer Reason
for Recall		The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
FDA Determined
Cause 2		Device Design
ActionHologic 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
Quantity in Commerce756 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KNW
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