Z-1512-2017Class II

Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been...

Name: Z-1512-2017 Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been...
Creator: Devicor Medical Products Inc
Published: 2017-02-28
License: https://open.fda.gov/license/

Devicor Medical Products Inc / initiated 2017-02-28 / Terminated / root cause: manufacturing process

FDA source

Devicor Medical Products Inc began a recall of Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance on 2017-02-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1512-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-28
Posted: 2017-03-08
Terminated: 2017-08-03
Recalling firm: Devicor Medical Products Inc
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
Product code: KNW Instrument, Biopsy
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: F11621304D1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1512-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1512-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21

Product code KNW

K152989Class IIMammotome revolve Dual Vacuum Assist Biopsy SystemDevicor Medical Products, Inc. / cleared 2016-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)