FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0275-2009
- Recalling firm
- Hologic, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-09-22
- Posted
- 2008-11-07
- Terminated
- 2009-11-18
- 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 during transport and expose dangerous sharp points to personnel handling the boxes. Upon receipt of the attached response form, Hologic will promptly send an equivalent amount of replacement product free of charge.
- Quantity
- 5,120 (1,024 cases of 5)
- Distribution
- Worldwide Distribution --- including USA and countries of Australia, Belgium, Brazil and Singapore.
- Lot, serial or model codes
- Lots 804038, 804050, 804067, 804085, 805049, 805054, 805064, 805080, 806004, 806016, 806051, 806066 and 806121.
- 510(k) numbers
- ["K010400","K042290"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 3003862400
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28