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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 Systemsee related information
Date Initiated by FirmFebruary 28, 2017
Date PostedMarch 08, 2017
Recall Status1 Terminated 3 on August 03, 2017
Recall NumberZ-1512-2017
Recall Event ID 76603
510(K)NumberK152989 
Product Classification Instrument, biopsy - Product Code KNW
ProductMammotome 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
FEI Number 3008492462
Recalling Firm/
Manufacturer		 Devicor Medical Products Inc
300 E Business Way Fl 5
Cincinnati OH 45241-2384
For Additional Information ContactJohn 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
ActionDevicor 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 Commerce320
DistributionWorldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
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 = KNW
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