Recall Z-1512-2017 ยท KNW Instrument, Biopsy
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
| Date | Mar 8, 2017 (initiated Feb 28, 2017) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152989 | Mammotome revolve Dual Vacuum Assist Biopsy System Devicor Medical Products, Inc., Feb 25, 2016 |