FDA Medical Device Recalls (openFDA)
Devicor Medical Products Inc: Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
- Recall number
- Z-1512-2017
- 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
- Status
- Terminated
- Initiated
- 2017-02-28
- Posted
- 2017-03-08
- Terminated
- 2017-08-03
- Reason
- 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
- 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
- 320
- Distribution
- Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
- Lot, serial or model codes
- F11621304D1
- 510(k) numbers
- ["K152989"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 3008492462
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28