Recall Z-2285-2010 ยท KNW Instrument, Biopsy
Hologic, Inc.
Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The handpiece is inserted into the breast to the site of interest. When the proper location/position is acheived, the handpiece cuts and removes biopsy tissue.
| Date | Aug 26, 2010 (initiated Aug 11, 2010) |
| Status | Terminated |
| Reason | The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20. |
| Root cause | Packaging |
| Action | The firm, Hologic, Inc., sent out "Urgent Medical Device Recall" letters by FedEx on August 11, 2010, to all customers. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to check their inventories and to quarantine any of the recalled product; if the product was distributed further, identify the users and notify them at once of this product recall; segregate all products from this lot and quarantine them in preparation for return to Hologic, and complete and return the enclosed RECALL RESPONSE FORM by fax at 877-574-3255 or mai |
| Quantity | 990 |
| Distribution | Worldwide distribution: USA and countries including Canada, Belgium, Algeria, Germany, London, Lebanon and Italy. |
| FDA record | Open on fda.gov |