FDA Recall
Terminated
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.
Recall: Z-1160-2010
·
Initiated February 1, 2010
Recall
- Recall Number
- Z-1160-2010
- Event Number
- 54619
- Firm
- Hologic, Inc.
- FEI Number
- 3003862400
- Product Code
- KNW
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- February 1, 2010
- Posted
- March 18, 2010
- Terminated
- October 8, 2010
- Address
- 6100 Technology Center Dr, Indianapolis, IN, 46278-6016
Description
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.
Reason
The product is labeled as ATEC0909-12 but it actually contains 0909-20.
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.
Distribution
US and Puerto Rico.
Quantity
190