Recall Z-1160-2010 ยท KNW Instrument, Biopsy
Hologic, Inc.
ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278. The handpiece is inserted into the breast to the site of the area of interest. When the proper location/[position is achieved, the handpiece cuts and removes biopsy tissue.
| Date | Mar 18, 2010 (initiated Feb 1, 2010) |
| Status | Terminated |
| Reason | The product is labeled as ATEC0909-12 but it actually contains 0909-20. |
| Root cause | Employee error |
| Action | Formal recall notification letters and response forms were sent to customers via FEDEX on February 1, 2010. If there are any questions, please call 317.344.7630. |
| Quantity | 190 |
| Distribution | US and Puerto Rico. |
| FDA record | Open on fda.gov |