Recall Z-0275-2009 ยท KNW Instrument, Biopsy
Hologic, Inc.
ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Model number ATEC 1212-20. Intended for partial or complete removal of tissue samples for diagnostic testing.
| Date | Nov 7, 2008 (initiated Sep 22, 2008) |
| Status | Terminated |
| Reason | The distal tip of the needle may become detached and remain in the patient, requiring surgical removal. |
| Root cause | Process control |
| Action | Consignees were notified via an Urgent Medical Device Recall letter dated 9/17/08 asking them to immediately check their inventories and quarantine all affected product from the listed lots. Also, if the product had been further distributed, users were to be identified and notified of the recall. Products are to be held in quarantine until they are returned to Hologic. The response form must be completed and returned to fulfill regulatory requirements and document actions taken at your facility. Handpieces whose pouches had been opened were to be destroyed, as they could potentially shift |
| Quantity | 5,120 (1,024 cases of 5) |
| Distribution | Worldwide Distribution --- including USA and countries of Australia, Belgium, Brazil and Singapore. |
| FDA record | Open on fda.gov |