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U.S. Department of Health and Human Services

Class 2 Device Recall Mammotome Revolve Dual Vacuum Assist Biopsy System

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  Class 2 Device Recall Mammotome Revolve Dual Vacuum Assist Biopsy System see related information
Date Initiated by Firm February 28, 2017
Date Posted March 08, 2017
Recall Status1 Terminated 3 on August 03, 2017
Recall Number Z-1512-2017
Recall Event ID 76603
510(K)Number K152989  
Product Classification Instrument, biopsy - Product Code KNW
Product Mammotome Revolve Dual Vacuum Assist Biopsy
System
The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Code Information F11621304D1
Recalling Firm/
Manufacturer		 Devicor Medical Products Inc
300 E Business Way Fl 5
Cincinnati OH 45241-2384
For Additional Information Contact John Scott Ehlert
513-864-9158
Manufacturer Reason
for Recall		 The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
FDA Determined
Cause 2		 Process control
Action Devicor sent an Urgent Medical Device Recall letter dated March 10, 2017 to all affected consignees via first class mail. The recall response rate will be tracked and reconciled by consignee's response form, certifications of product inventory, and/or disposal. Consignees were asked to complete and return the enclosed response form as soon as possible. Consignees with any questions were instructed to call Mammotome Customer Service at 1-877-926-2666. For questions regarding this recall call 513-864-9158.
Quantity in Commerce 320
Distribution Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = DEVICOR MEDICAL PRODUCTS, INC.
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