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U.S. Department of Health and Human Services

Class 2 Device Recall Mammotome HydroMARK

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 Class 2 Device Recall Mammotome HydroMARKsee related information
Date Initiated by FirmMarch 30, 2022
Create DateMay 23, 2022
Recall Status1 Terminated 3 on April 30, 2024
Recall NumberZ-1124-2022
Recall Event ID 90119
510(K)NumberK210752 
Product Classification Marker, radiographic, implantable - Product Code NEU
ProductHydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Code Information UDI-DI: 00841911102472 Lot F12201281D
Recalling Firm/
Manufacturer		 Devicor Medical Products Inc
300 E Business Way Fl 5
Cincinnati OH 45241-2384
For Additional Information Contact
513-864-9178
Manufacturer Reason
for Recall		Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
FDA Determined
Cause 2		Labeling Change Control
ActionOn March 30, 2022, the firm distributed Urgent Medical Device Recall letters to their customers via email. Customers were informed of the labeling issue. Users were instructed to examine their inventory and identify any affected product. Users should contact their local sales representative for correction of any affected devices. The sales representative will be on site to remove the affected patient labels. Please do not use affected patient labels from this lot. If you have any additional questions, comments or concerns please contact the firm's Customer Support at +1 877-926-2666. You may also email mmtchnrecall@mammotome.com.
Quantity in Commerce90 devices
DistributionUS Nationwide distribution in the states of DE, KY, NY, OH, WV.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NEU
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